chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, Sluggishness
Clinical narrative: I went and got my vaccine and then it started coming on more/Little sluggish for a couple of days/I ended up getting sick; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I went and got my vaccine and then it started coming on more/Little sluggish for a couple of days/I ended up getting sick) in a male patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I went and got my vaccine and then it started coming on more/Little sluggish for a couple of days/I ended up getting sick). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (I went and got my vaccine and then it started coming on more/Little sluggish for a couple of days/I ended up getting sick) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication information was not provided.  Patient and his daughter got COVID. Patient got COVID a while back ago. The first day that he heard that his daughter who was living in a single studio apartment became sick, he went and got his vaccine and then it started coming on more and he ended up getting sick. He got the Paxlovid pills from the physician, took those for 5 days and was fine. He was a little sluggish for a couple of days. His daughter also received the pills.  He would get another shot on the day of report to make sure he did not get it again as he heard that the vaccine lasted for about 6 months.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Nervousness
Clinical narrative: feeling shaken harshly back and forth but not harshly; feeling pressure in their head while driving after receiving vaccine; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (feeling pressure in their head while driving after receiving vaccine) and NERVOUSNESS (feeling shaken harshly back and forth but not harshly) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 16-Apr-2025,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced HEAD DISCOMFORT (feeling pressure in their head while driving after receiving vaccine). On 18-Apr-2025, the patient experienced NERVOUSNESS (feeling shaken harshly back and forth but not harshly). At the time of the report, HEAD DISCOMFORT (feeling pressure in their head while driving after receiving vaccine) had not resolved and NERVOUSNESS (feeling shaken harshly back and forth but not harshly) outcome was unknown.      The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   No concomitant medications were reported.  It was reported that on 16-Apr-2025 and 18-Apr-2025, patient felt a lot of pressure in her head while driving. On 16-Apr-2025, it was resolved after she reached home, but she was afraid to drive again later that day. On 17-Apr-2025, she drove without any problem. Later, on 18-Apr-2025, it happened again while driving. It almost felt like she was shaken back and forth but not harshly. She wanted to know if there was something she should be concerned about.   It was unknown if the patient experienced any additional symptoms or events  No treatment medications were reported.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site reaction redness; Injection site reaction: swelling; Injection site reaction: warm; Injection site reaction: itching; Injection site reaction: mild pain; gestational_period: 37; gestational_period: 37; This is a spontaneous report received from a Pharmacist.  A 33-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Apr2025 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years for maternal immunisation. The patient's relevant medical history included: "Allergy: Sulfa drugs" (unspecified if ongoing). The patient was 37 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 37 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 05May2025. Concomitant medication(s) included: TDAP taken for immunisation, on 25Mar2025 as dose number unknown, single. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 10Apr2025 at 10:00, outcome "unknown" and all described as "gestational_period: 37"; VACCINATION SITE ERYTHEMA (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction redness"; VACCINATION SITE PRURITUS (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: itching"; VACCINATION SITE PAIN (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: mild pain"; VACCINATION SITE SWELLING (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: swelling"; VACCINATION SITE WARMTH (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: warm". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling, vaccination site warmth, vaccination site pruritus, vaccination site pain.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth
Clinical narrative: Injection site reaction redness; Injection site reaction: swelling; Injection site reaction: warm; Injection site reaction: itching; Injection site reaction: mild pain; gestational_period: 37; gestational_period: 37; This is a spontaneous report received from a Pharmacist.  A 33-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Apr2025 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years for maternal immunisation. The patient's relevant medical history included: "Allergy: Sulfa drugs" (unspecified if ongoing). The patient was 37 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 37 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 05May2025. Concomitant medication(s) included: TDAP taken for immunisation, on 25Mar2025 as dose number unknown, single. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 10Apr2025 at 10:00, outcome "unknown" and all described as "gestational_period: 37"; VACCINATION SITE ERYTHEMA (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction redness"; VACCINATION SITE PRURITUS (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: itching"; VACCINATION SITE PAIN (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: mild pain"; VACCINATION SITE SWELLING (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: swelling"; VACCINATION SITE WARMTH (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: warm". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling, vaccination site warmth, vaccination site pruritus, vaccination site pain.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiparesis, Palpitations, Paraesthesia, Tremor
Clinical narrative: left sided neurological issues, including tremors & tingling, weakness; intermittent heart palpitations; left sided neurological issues, including tremors & tingling, weakness; left sided neurological issues, including tremors & tingling, weakness; This is a spontaneous report received from a Physician from a sales representative.  A 74-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dsoe 1, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset Nov2024, outcome "not recovered", described as "intermittent heart palpitations"; HEMIPARESIS (medically significant), TREMOR (non-serious), PARAESTHESIA (non-serious) all with onset Nov2024, outcome "not recovered" and all described as "left sided neurological issues, including tremors & tingling, weakness". Therapeutic measures were taken as a result of hemiparesis, palpitations, tremor, paraesthesia.  Clinical course: Experiencing intermittent heart palpitations, left sided neurological issues, including tremors & tingling, weakness. Periodic flare-ups of these symptoms. Patient was received Physical therapy as treatment received for the adverse event. Patient was not received any other vaccines on the same date as the vaccine(s) and other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported event Hemiparesis and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Ventricular extrasystoles
Clinical narrative: Premature Ventricular Contractions - trigeminal pattern; shortness of breath; reduced energy; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Aug2021 as dose 2, single (Lot number: FC3180) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism and High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: May2017; HYDROCHLOROTHIAZIDE, start date: Jan2020; LOSARTAN, start date: Sep2020. Past drug history included: Lisinopril, reaction(s): "Hypersensitivity". Vaccination history included: comirnaty (DOSE 1, SINGLE, Lot number: EW0198), administration date: 19Jul2021, for Covid-19 immunisation. The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious) with onset 01Oct2022, outcome "not recovered", described as "Premature Ventricular Contractions - trigeminal pattern"; ASTHENIA (non-serious) with onset 01Oct2022, outcome "not recovered", described as "reduced energy"; DYSPNOEA (non-serious) with onset 01Oct2022, outcome "not recovered", described as "shortness of breath". Therapeutic measures were taken as a result of ventricular extrasystoles, dyspnoea, asthenia.  Additional information: The patient did not receive any other vaccines on the same date as the vaccine and did not receive any other vaccines within 4 weeks PRIOR to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting. Reported Event:  Not long after taking the vaccines patient got where had shortness of breath and reduced energy. And about a year and a half later it got worse and when went to  doctor at the time did an EKG and it was abnormal, so they got an appointment with Dr. with Cardiology and several thousand dollars later was diagnosed with Premature Ventricular Contractions - trigeminal pattern. And on last Doctors appointment two weeks ago every other heartbeat is a PVC. Have been on three different medications to try and control them. The Nurse Practitioner who gave me the first EKG was having the same issue, and she said hers was from the vaccine also. Metroprolol , then Flecainide and now Amiodarone was taken as treatment for events; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500084867 same event, similar drug and different patient.;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 27Feb2023 I tested positive for covid, after having all of the vaccines; 27Feb2023 I tested positive for covid, after having all of the vaccines; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "muscle problems" (unspecified if ongoing), notes: statins may be causing muscle problems. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "my ears ring"; Aspirin, reaction(s): "Reaction: Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Feb2023, outcome "recovered with sequelae" and all described as "27Feb2023 I tested positive for covid, after having all of the vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 27Feb2023 tested positive for covid, after having all of the vaccines. In a day or 2 started on Paxlovid. Patient took it for the prescribed time (5 days) and began to feel better. But the following week (13Mar) covid came back and lasted until the 18th. and experienced a bad taste with the paxlovid, which she expected, but what she didn't expect was the nausea and diarrhea. She had many attacks of both over the next several months. But the attacks got further apart until she don't have the diarrhea very often now. But she still gets the nausea. She honestly doesn't know if it's from the paxlovid or the covid itself; but it began with the paxlovid, so I found this site and am reporting it. OTC anti-diahrrea and prescribe nausea med was prescribed as treatment for the event.   Batch/lot number is not provided, and it cannot be obtained.
Vaccine: DTAP, HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: n giving Act Hib reconstituted with Daptacel at the 15-month visit with no reported adverse event; Initial information received on 15-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] reconstituted with diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] at the 15-month visit with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) reconstituted with diphtheria-15/tetanus/5 AC pertussis vaccine at the 15-month visit with no reported adverse event (product preparation error) (unknown latency)  Information on the batch number could not be requested corresponding to the one at time of event occurrence  Reportedly, reporter stated that, I have an account that has been giving Act Hib reconstituted with Daptacel at the 15-month visit. The account has not been using the diluent that comes with Act Hib they have been using Daptacel as the diluent. Nurses state that the rep, 15 years ago, informed them that they could use Daptacel to reconstitute Act Hib.   Action taken was not applicable.   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.
Vaccine: DTAP, HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: they reconstituted act-hib with Daptacel instead of the provided diluent with no reported adverse event; Initial information received on 15-Apr-2025 (with live follow up received on 15-APR-2025) regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who who received HIB (PRP/T) vaccine [ACT-HIB] reconstituted with diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] 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 unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) reconstituted with diphtheria-15/tetanus/5 AC pertussis vaccine at the 15-month visit with no reported adverse event (product preparation error) (unknown latency).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly- Caller mentioned that the DTap was Daptacel and the situation has been a practice for years and there were over 2000 patients administered.  Action taken was not applicable.  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: 42.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: adminsitered post excursion with no adverse event; temperature excursion of fluzone Max/low temperature reached: 8.5 °C to 8.8 °C Duration: 30minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases- US-SA- 2025SA114290.  This case involves a 42 years old male patient who was administered INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE]  post excursion with no adverse event and temperature excursion of fluzone max/low temperature reached: 8.5 °c to 8.8 °c duration: 30minutes 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, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation.  On 04-APR-2025 temperature excursion of fluzone max/low temperature reached: 8.5 °c to 8.8 °c duration: 30minutes with no reported adverse event (product storage error) (unknown latency).  On 14-Apr-2025, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE Suspension for injection (strength standard) dose 0.5 ml, 1x (once) lot U8442BA expiry date-20-Jun-2025 via intramuscular route in the left deltoid for influenza administered post excursion with no adverse event (poor quality product administered) (latency same day).  Cause of excursion-Human error (Reason: Monthly cycle count, inventory checking) and patient did not report any adverse events  Action taken: not applicable.   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.; Sender's Comments:  US-SA-2025SA113376:cluster case US-SA-2025SA114290:Master case
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Max/low temperature reached: 8.5 °C to 8.8 °C Duration: 30 minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 58 years old male patient who received influenza USP TRIVAL A-B subvirion vaccine [Fluzone] and the vaccine was exposed to temperature excursion where max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes 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 for Immunisation.  On 04-Apr-2025, influenza USP TRIVAL A-B subvirion vaccine [Fluzone] Suspension for injection (strength- standard, expiry date- 20-JUN-2025and lot U8442BA) for Influenza immunisation was exposed to temperature excursion where max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes with no reported adverse event (product storage error).   On 14-Apr-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion vaccine via intramuscular route in the right deltoid.  Reportedly, reason: Monthly cycle count, inventory checking. There was no previous excursion. Human error was involved. Product was administered post excursion.   Action taken was not applicable.   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.  ; Sender's Comments:  US-SA-2025SA114282:cluster case US-SA-2025SA114290: US-SA-2025SA113257:
Age: 11.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Meningococcal B vaccine was given out of the prefered age for vaccination. Age for vaccination is 16 through 18 years, patient was 11 years old when he got this vaccine.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Patient was fussy and irritable starting a few hours after injection. She maintained a fever for about 24 hrs, as well as developed a rash all over her body that was lasted  several days.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Genital rash, Hypersensitivity, Rash, Rash pruritic
Clinical narrative: Patient developed fiery painful and itchy rash on torso, spreading to chest, and the worst was in her thighs and genital area (she is potty trained and does not wear diapers - could not be ?diaper rash?)  Had to dose her with allergy medicine for this allergic reaction
Age: 7.0
Sex: F
Vaccine: PNC20
Symptoms: No adverse event, Wrong product administered
Clinical narrative: NO ADVERSE EVENTS, REPORTING WRONG VACCINE ADMINISTERED BY PROVIDER.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC20
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: SLIGHTLY RED AND SMALL RASH ON LEFT THIGH FROM DTAP BEING GIVEN
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Cellulitis
Clinical narrative: PATIENT REPORTS DEVELOPING CELLULITIS AS A RESULT OF THIS VACCINE FOUR DAYS AFTER VACCINATION
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Pt was given MMR vaccine that was expired 2 days prior. Expired on 4/19/2025 and given 4/22/2025
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Pt brought in rx for MMR vaccine, Shingrix, Twinrix, Boostrix, Prevnar, from Dr. for MMR
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient had swelling in left arm and rash in her body
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Magnetic resonance imaging joint, Magnetic resonance imaging neck, Pain, Pain in extremity
Clinical narrative: My left arm started hurting about 1 month after that vaccine & still having chronic pain in left arm.  I saw NP 12/4/25. & she ordered an x-ray of my left arm & put me on gabapentin  on 12/23/24.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray limb
Clinical narrative: My left arm started hurting about 1 month after that vaccine & still having chronic pain in left arm.  I saw NP 12/4/25. & she ordered an x-ray of my left arm & put me on gabapentin  on 12/23/24.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Injection site erythema, Injection site pain
Clinical narrative: Patient received a second dose of Arexvy on 4/17/2025. He received a dose previously on 1/24/2024. He felt some soreness and redness at the injection site that resolved after 3 days
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Pruritus, Urticaria
Clinical narrative: Patient  began feeling "a little itchy" 2 hrs after administration, 2 hrs after this, her throat began getting itchy, her back and throat was itchy. The next day her she had small hives (not very raised) on her chest, neck, middle of back side.  She managed symptoms with oral benadryl daily.  Pt reports that whenever she was active and her BP, body temp rises with exertion, she felt the itchiness on neck and arm areas again.  She reported these effects to pharmacy 5 days post vaccination. Symptoms are improving with benadryl use, pt will update with any changes.
Age: 77.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Dysstasia, Measles antibody positive, Mumps antibody test negative, Pyrexia
Clinical narrative: Low grade fever 99F-100F (<100.4F) started 11 days post-vaccination, lasting 2-3 days, rising to high-grade fever up to 103F for another 3-5 days, after which diffuse rash appeared and lasted for 4 days with no appetite, followed by another 3-4 days of intense vertigo (patient unable to stand or move without holding onto furniture or walls). She denied any respiratory symptoms and reported a total of ~2 weeks of symptoms that ultimately resolved 3 days before her return to clinic for planned 2nd MMR dose (was scheduled for 4/17/25). After lengthy discussion with RN and consultation with ordering physician, vaccination was postponed and titers were drawn to determine best plan of care.
Age: 77.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rubella antibody positive, Vertigo
Clinical narrative: Low grade fever 99F-100F (<100.4F) started 11 days post-vaccination, lasting 2-3 days, rising to high-grade fever up to 103F for another 3-5 days, after which diffuse rash appeared and lasted for 4 days with no appetite, followed by another 3-4 days of intense vertigo (patient unable to stand or move without holding onto furniture or walls). She denied any respiratory symptoms and reported a total of ~2 weeks of symptoms that ultimately resolved 3 days before her return to clinic for planned 2nd MMR dose (was scheduled for 4/17/25). After lengthy discussion with RN and consultation with ordering physician, vaccination was postponed and titers were drawn to determine best plan of care.
Age: 58.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pt reported to the pharmacy with arm soreness reaching from shoulder to wrist with tingling in her fingers. She says that the pain started after receiving Shingles and pneumonia vaccines in the left arm 2 weeks ago. Pt was advised to go to the doctors office where she was prescribed naproxen. Pt came back saying that the doctor told her that, based on her own description of where the vaccine was given, the vaccine was given too low and could have caused her problems.
Age: 66.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: red rash on right arm below injection site. hot, itchy
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose, Dizziness, Syncope, Vomiting
Clinical narrative: patient felt lightheaded, and had syncopal episode  with vomiting shortly after vaccine. After vomiting she felt better
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Pain
Clinical narrative: BRUSING AT INJECTION SITE, PAIN RADIATING DOWN TO LOWER ARM FOR OVER A WEEK.
Age: 14.0
Sex: M
Vaccine: IPV, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient accidentally received a duplicate dose of all three vaccines: MedQuafi, Adacel and IPOL. First dose administered was 4/17/2025, and second round of doses were administered the next day on 4/18/2025. No adverse signs or symptoms were observed or reported by the patient. The patient's guardian was contacted and informed of the error, and was advised by the physician accordingly, with no additional questions or concerns.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RSV, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: -baby was double dosed on RSV vaccine this season. Baby monitored extra time. No reaction occurred.
Age: 62.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Feeling hot, Pain in extremity, Rash
Clinical narrative: Pt presented states her arm hurt, had a rash and was hot
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood creatine phosphokinase normal, C-reactive protein increased, Full blood count normal, Headache, Injected limb mobility decreased
Clinical narrative: Pain L arm, decreased ROM L arm, nausea, headache. R arm normal.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Metabolic function test normal, Nausea, Pain in extremity
Clinical narrative: Pain L arm, decreased ROM L arm, nausea, headache. R arm normal.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: A HCP called to report that a shipment of VARIVAX was received on 02/23/2025 and inadvertently placed in the refrigerator until a dose of the VARIVAX was inadvertently administered to a patient on 03/09/2025 in which the improper storage was identifi; The  HCP reported that the patient did not experience any adverse issues or side effects from the administered dose.; This spontaneous report has been received from a pharmacist, regarding to a patient of 36-years-old of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with improperly stored of  Varicella Virus Vaccine Live (Oka-Merck) lyophilisate and solvent for solution for injection (VARIVAX) at a dose of 0.5 milliliters (ml), once, (lot number Y013347, expiration date 02-AUG-2026), with a sterile diluent, solution for injection (lot number 2053173, expiration date 23-MAR-2027) both administered as prophylaxis. The administered dose was stored at a temperature of 41.1 degrees Fahrenheit (F) during a time frame of 14 days (product storage error). There was no previous temperature excursion. No additional side effects were reported in the patients.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Paraesthesia oral, Swelling, Urticaria
Clinical narrative: tingling in lips; Nerve pain in teeth; swelling; Hives; This non-serious case was reported by a consumer and described the occurrence of tingling lips in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-JAN-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tingling lips (Verbatim: tingling in lips), nerve pain (Verbatim: Nerve pain in teeth), swelling (Verbatim: swelling) and hives (Verbatim: Hives). The outcome of the tingling lips was not resolved and the outcome of the nerve pain, swelling and hives were resolved with sequelae.   It was unknown if the reporter considered the tingling lips, nerve pain, swelling and hives to be related to Shingrix.     It was unknown if the company considered the tingling lips, nerve pain, swelling and hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-APR-2025 The patient never reacted to a vaccine - other than COVID before. It was reported that the patient was really looking for someone to tell if she should get the second shot. The patient didn't want shingles but She was 3 months out from first shot and was still tingly in her lips. (Nerve pain in teeth, tingling in lips and swelling, hives) Were the symptoms treated was reported as no Other Products were reported as no
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Eye movement disorder, Hypotonia, Unresponsive to stimuli
Clinical narrative: Approximately 4-5 minutes after vaccine became limp and unresponsive with eyes rolled back into his head. He was back to baseline within 30 minutes without residual symptoms. I suspect this is a hypotonic-hyporesponsive episode
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Organ failure, Scar, Vaccination failure
Clinical narrative: Organ failure; Suspected vaccination failure; developed shingles/still had the shingles scars on him; This serious case was reported by a consumer via interactive digital media and described the occurrence of organ failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced organ failure (Verbatim: Organ failure) (serious criteria death), vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed shingles/still had the shingles scars on him). The outcome of the vaccination failure and shingles were not reported. The reported cause of death was organ failure.   It was unknown if the reporter considered the organ failure, vaccination failure and shingles to be related to Shingles vaccine.     The company considered the organ failure and vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-APR-2025 This case was reported by a patient's wife via interactive digital media. The reporter stated that her late husband developed shingles less than a year after they both were vaccinated. He died of organ failure at about a year out. He still had the shingles scars on him. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Organ failure is an unlisted event which is considered unrelated to GSK Shingles vaccine.  Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.; Reported Cause(s) of Death: Organ failure
Vaccine: RVX
Symptoms: Malaise, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; only had it for 3-4 days; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: only had it for 3-4 days). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was resolved.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 12-APR-2025 This case was reported by a patient via interactive digital media. The patient had RSV vaccine last year and it was bad but because the patient had been vaccinated only had it for 3 to 4 days.  After the vaccination the patient was really sick but only for a few days. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Max/low temperature reached: 8.5 °C to 8.8 °C Duration: 30 minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to US-SA-2025SA112035  This case involves a 64 years old male patient who received influenza USP TRIVAL A-B subvirion vaccine [Fluzone] which was exposed to temperature excursion where max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Apr-2025, influenza USP TRIVAL A-B subvirion vaccine [Fluzone] Suspension for injection (once) (strength- standard, expiry date- 20-Jun-2025and lot U8442BA) for Influenza immunisation was exposed to temperature excursion where max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes with no reported adverse event (product storage error).   On 10-Apr-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion vaccine via intramuscular route in the right deltoid for immunization.  Reportedly, reason: Monthly cycle count, inventory checking. There was no previous excursion. Human error was involved. Product was administered post excursion.   Action taken was not applicable.   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.; Sender's Comments:  US-SA-2025SA114290: US-SA-2025SA113179: US-SA-2025SA113257: US-SA-2025SA112035:Master case
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Eye swelling
Clinical narrative: Mother called PPA at 2:20 pm to report bilateral eye swelling and one red spot located on the pt's skin. No SOB, cough or wheeze. Mother advised to have pt seen at the ED. Pt was then seen at ED, Epi-Pen administered and then pt was observed for 5 hours. Pt was then discharged.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient here for annual well visit. Received an unnecessary 3rd dose of HPV at beginning of visit. Patient did not have any adverse reaction following administration of the vaccine.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was determined to be out of the optimal temperature range for storage. No symptoms observed or reported at time of administration. No additional treatment was required. Pfizer unable to provide viability of vaccinations stored outside of the advised temperature range. Patient and parent was informed and will vaccinate again in the fall.
Age: 41.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Underdose
Clinical narrative: PATIENT WAS GIVEN A VACCINE MADE FOR PREDIATRICS 12MO-12YRS. THERE WERE NO ADVERSE REACTIONS, NO SIDE AFFECTS, NO SYMPTOMS
Age: 83.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site bruising, Rash
Clinical narrative: After first vaccinations he had a rash on his Left shoulder that went around his arm. It is now gone. The injection on the right should still has a black and blue bruise on it
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: Patient received vaccines at approximately 5:30 PM without incident. Remained seated on exam table and assisted by mother with buttoning shirt while eating crackers and juice provided prior to vaccine administration. Stood from exam table to exit immunization room at approximately 5:35 PM. Color became pale. Patient was asked to return to exam table, and was assisted by RN. Patient verbalized that she felt "dizzy." RN and mother remained by patient as she experienced syncopal episode at approximately 5:37 PM and was gently lowered to floor by RN. Code Blue called. Nurses  and CSR  responded immediately. Patient alert and oriented upon being lowered to floor. Vitals obtained at 5:40 PM: BP 119/59, pulse 100. Ice packs applied to forehead, base of neck, and fan provided per patient request. Patient continues to converse with staff and mother present. Vitals obtained at 5:45 PM: BP 105/70, pulse 90. Patient reports starting to feel "normal." Assisted to sitting position by staff. Remained in sitting position for approximately 10 minutes. Provided crackers and juice per patient request. Vitals obtained at 5:50 PM: BP 109/62, pulse 90. Patient states she feels like she is able to attempt to stand. Assisted by staff to standing position. Vitals obtained at 5:55 PM: BP 110/67, pulse 86. Mother counseled on syncopal episode, and encouraged to continue to monitor daughter and seek medical attention if needed. Also encouraged adequate intake and rest following visit. Mother verbalizes understanding. Patient states that she feels better. Was assisted to waiting area by staff and was visualized exiting building with mother and grandfather at approximately 6:05 PM.
Age: 1.42
Sex: F
Vaccine: MMR, RV1
Symptoms: Abdominal pain, Contusion, Crying, Differential white blood cell count, Full blood count
Clinical narrative: Rotavirus vaccine: severe abdominal pain resulting in inconsolable crying for 6 hours starting 2 hours after vaccine administration.      MMR: Thrombocytopenic Purpura within 3 weeks of vaccine administration. Resulted in emergent hematology consultations and lab tests.
Age: 1.42
Sex: F
Vaccine: MMR, RV1
Symptoms: Immune thrombocytopenia
Clinical narrative: Rotavirus vaccine: severe abdominal pain resulting in inconsolable crying for 6 hours starting 2 hours after vaccine administration.      MMR: Thrombocytopenic Purpura within 3 weeks of vaccine administration. Resulted in emergent hematology consultations and lab tests.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Rash, Skin warm
Clinical narrative: large rash to left arm, warm to touch, getting larger as time goes on.
Age: 1.42
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Rash, Respiratory tract congestion
Clinical narrative: pt broke out in a rash on the face and chest, mom took her to the ER  on 04/13 or 04/14 because she was having trouble with congestion, possible trouble breathing related to acute bronchiolitis, she was then transferred to and admitted, from our understanding the rash brought concern for measles due to the recent outbreaks, mom actually told the local ER staff that she had not had any MMR vaccine
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received extra dose of Kinrix (previous on 2/14/2025) instead of receiving Proquad. No adverse effects noted. Patient to return at a later time to receive correct vaccine.
Age: 51.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Patient states the night of the vaccine, she experienced  malaise, fever and chills.  The next day at work, April 16, she experienced right arm swelling. On April 17th, she sought care of her primary care physician who diagnosed her with cellulitis. The patient states she was given Rocephin and Amoxicillin.
Age: 56.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Erythema
Clinical narrative: high fever, chills, soaking sweat, nausea,vomiting,diarrhea, extreme pain in arm (can't move and sleep on that side),redness on entire upper arm, no energy, dizziness when lying down,very fatigued,itching
Age: 56.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Fatigue, Hyperhidrosis, Nausea, Pain in extremity, Pruritus
Clinical narrative: high fever, chills, soaking sweat, nausea,vomiting,diarrhea, extreme pain in arm (can't move and sleep on that side),redness on entire upper arm, no energy, dizziness when lying down,very fatigued,itching
Age: 56.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Pyrexia, Sleep disorder, Vomiting
Clinical narrative: high fever, chills, soaking sweat, nausea,vomiting,diarrhea, extreme pain in arm (can't move and sleep on that side),redness on entire upper arm, no energy, dizziness when lying down,very fatigued,itching
Age: 61.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Blindness transient
Clinical narrative: The morning following the vaccination pt experiened 5 minutes of loss of sight and black vision.  Her vision returned to normal after 5 minutes.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Neuralgia, Tendon disorder, Ultrasound joint
Clinical narrative: 1/16/25 pt received flu vaccine.  On 4/1/25 pt was here for a visit and complained of right shoulder pain, nerve pain since flu shot was given. pt took Motrin which did not help
Age: 8.0
Sex: F
Vaccine: COVID19, FLU3, IPV, TDAP
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Client complained of dizziness immediately after receiving the vaccines. Her mother said it had happened before after receiving vaccines. I gave the client water, some snacks and she was observed for 30 minutes. She stated she felt better her mother took her home.