chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Incorrect route of administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix (subcutaneous). On an unknown date, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Incorrect route of administration). The outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-DEC-2024 Boostrix inadvertently administered via the subcutaneous route (patient does not have a bleeding disorder), which led intramuscular formulation administered by other route. Evaluating whether an additional dose was needed. Looking for any data on vaccine absorption via the subcutaneous route verses the intramuscular route, or any literature on redosing the vaccine.
Age: 2.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: patient received a dose of Boostrix instead of Flulaval this morning.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3BH5K, expiry date 22-JAN-2027) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On 20-DEC-2024, the patient received Boostrix. On an unknown date, the patient received FluLaval Quadrivalent. On 20-DEC-2024, immediately after receiving Boostrix and not applicable after receiving FluLaval Quadrivalent, the patient experienced wrong vaccine administered (Verbatim: patient received a dose of Boostrix instead of Flulaval this morning.). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:20-DEC-2024 The HCP called to report that a 2-year-old, female patient received a dose of Boostrix instead of Flulaval which led to wrong vaccine administered. There were no side effects reported. They were inquiring how to proceed.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: diluent only given; diluent only given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number TJ534, expiry date 23-OCT-2026) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date).   On 20-DEC-2024, the patient received the 2nd dose of Shingrix. On 20-DEC-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: diluent only given) and inappropriate dose of vaccine administered (Verbatim: diluent only given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-DEC-2024 The pharmacist reported that they just gave shingles vaccine to a patient, except they used two diluents on accident.  The technician that did it, pulled out a diluent, put it into another diluent and then withdrew 0.5 mL and gave it. The specialist confirmed there was no powder used, and the patient received only the adjuvant portion of the vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was the patient's second dose in the series.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: accidentally administered an extra dose of Menveo (1-vial) on December 20th 2024. Patient got a prior dose of Menveo back in October 24th 2024; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB030A, expiry date 31-DEC-2025) and (batch number EK7DG, expiry date 31-DEC-2025) for prophylaxis.   Previously administered products included Menactra (received a dose on 16-OCT-2018). Concomitant products included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO).   On 20-DEC-2024, the patient received the 2nd dose of Menveo. On 20-DEC-2024, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: accidentally administered an extra dose of Menveo (1-vial) on December 20th 2024. Patient got a prior dose of Menveo back in October 24th 2024). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 20-DEC-2024 The physician stated they accidentally administered an extra dose of Menveo on 20th December 2024 which led to extra dose administered. The patient got a prior dose of Menveo back in 24th October 2024 and before that they got Menactra back in 16th October 2018.
Sex: U
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: I've gained 80lbs; This spontaneous report received from a patient by a company representative concerned a patient of unspecified age and sex. The report was received from J&J managed social media. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, frequency and therapy dates not reported, for covid-19 prophylaxis.  No concomitant medications were reported.  On an unspecified date, the patient experienced i've gained 80lbs. The patient reported that they were not fat but ever since receiving the covid-19 vaccine had gained 80lbs and did not think they were alone.  The action taken with janssen covid-19 vaccine was not applicable.  The outcome of i've gained 80lbs was not reported.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: severe Medical issues; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. Additional reporter noted as Lawyer. Document was received in the form Legal Summons and Complaint, EZ report and central compliant vigilance. Initial document was processed along with additional document received on 10-DEC-2024. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: Dose series 1, for covid-19 prophylaxis.  No concomitant medications were reported.  On an unspecified date, the patient experienced severe medical issues. after taking COVID-19 shot. (dose series is 1). The action taken with janssen covid-19 vaccine was not applicable.  The outcome of severe medical issues was not reported.  This report was associated with a product quality complaint: Product Complaint 90000347803.  Investigation Results: Although a definitive root cause could not be determined for this case, this complaint record will be included in the periodic product quality complaint trending.  This report was serious (other medically important condition).; Sender's Comments: V0: Medical assessment comment is not required per standard procedure as the case is a legal case.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Severe Medical issues; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. Additional reporter noted as Lawyer. Document was received in the form Legal Summons and Complaint and EZ report. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series: 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch or lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced severe medical issues. after taking COVID-19 shot. (dose series is 1).  The action taken with janssen covid-19 vaccine was not applicable.  The outcome of severe medical issues was not reported.  This report was serious (other medically important condition).; Sender's Comments: V0; Medical Assessment comment not required per standard procedure as it is legal case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Could get medical records, rapid heart palpitation forgot name. On meds for rest of my life.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test, Incorrect dose administered, No adverse event
Clinical narrative: No adverse reactions to the event
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: R arm swelling and redness
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test, No adverse event
Clinical narrative: No adverse events
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Product storage error
Clinical narrative: Vaccines deemed not stable due to temperature excursion
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: There are no reported adverse effects; pt was held for the duration of the session.
Age: 1.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Feeling abnormal, Migraine, Nausea
Clinical narrative: Employee was given the Hep B vaccination on 01/13/25 at 1530, clocked out at 1700 and went home.  Employee called center this morning (01/14/25) to report that after getting home last night she felt bad and went to bed.  Employee also states that she got up at 0400 and had diarrhea, nausea, and a migraine.  Also had a fever of 99.3 which she took Tylenol at that time.  Instructed employee to drink water to stay hydrated and rest.
Age: 2.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Product preparation issue
Clinical narrative: MA intended to administer a varicella vaccine, however she did not prep correctly and administered diluent only.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site mass, Injection site pain, Pain
Clinical narrative: .  It was sore from the very beginning and she could feel a small lump right where it was injected.  It never improved.  Started as intermittent pain with isolated movements and has since become constant pain radiating down her arm toward forearm/wrist.  She was trying various things, heat, frequent movement/stretches, rest, medications.  She has now been referred to ortho.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Nervous system disorder, Pain, Vaccination site induration, X-ray normal
Clinical narrative: .  It was sore from the very beginning and she could feel a small lump right where it was injected.  It never improved.  Started as intermittent pain with isolated movements and has since become constant pain radiating down her arm toward forearm/wrist.  She was trying various things, heat, frequent movement/stretches, rest, medications.  She has now been referred to ortho.
Age: 51.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Facial paralysis, Magnetic resonance imaging
Clinical narrative: According to a patient statement, the symptoms started showing 5 days later after she received the 2 vaccinations including flu and covid shots. She could not move the facial muscles and half of her face droop. She went to ER and did several tests, and then got diagnosed as Bell's palsy.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Breast pain, Chills, Dizziness, Headache
Clinical narrative: Arm pain following tdap vaccination. Patient was seen in the ED notes state: The patient states that she received her tdap immunization at 1030 on 12/16/24. That evening, around 1630, she had onset of chills, subjective fever, lightheadedness, diaphoresis, headache, myalgias, and nausea. Since then the pain has moved into the left breast and axilla. With this notes limited range of motion of the left arm.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Injected limb mobility decreased, Myalgia, Nausea, Pain in extremity
Clinical narrative: Arm pain following tdap vaccination. Patient was seen in the ED notes state: The patient states that she received her tdap immunization at 1030 on 12/16/24. That evening, around 1630, she had onset of chills, subjective fever, lightheadedness, diaphoresis, headache, myalgias, and nausea. Since then the pain has moved into the left breast and axilla. With this notes limited range of motion of the left arm.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Arm pain following tdap vaccination. Patient was seen in the ED notes state: The patient states that she received her tdap immunization at 1030 on 12/16/24. That evening, around 1630, she had onset of chills, subjective fever, lightheadedness, diaphoresis, headache, myalgias, and nausea. Since then the pain has moved into the left breast and axilla. With this notes limited range of motion of the left arm.
Age: 61.0
Sex: M
Vaccine: EBZR
Symptoms: Asthenia, Blood test, Cytogenetic analysis, Electromyogram, Immunoglobulin therapy
Clinical narrative: Continuous loss of hand strength
Age: 61.0
Sex: M
Vaccine: EBZR
Symptoms: Pulmonary function test
Clinical narrative: Continuous loss of hand strength
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 12.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 17.0
Sex: F
Vaccine: HPV9, IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired date 1/2/2025, given 1/9/2025. Patient and guardian notified. Patient acknowledged that vaccine was expired. Patient denies any adverse effects. Patient told to report any adverse effects of vaccine to City Health Department, and told to schedule appointment for replacement vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Throat irritation
Clinical narrative: 01/4/2025 1020 FLU Vaccine given. 1045 patient complained of dizziness, flushed face and itchy throat. Allegra 60 mg given po per protocol. Called EMS. Came and evaluate patient. Patient refused to go to ER and signed AMA. Patient states she does not feel dizzy anymore and left Occupational Health Office at 1115.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chest pain, Crying, Discomfort
Clinical narrative: 5 hours post injection pt reports fits of crying, injection site pain, shoulder pain, neck pain, sternum pain, back pain.  ROM difficulty.  Pt was anxious prior to injection.  Pt seen next day with continued discomfort.  No obvious swelling redness.  Still c/o ROM difficulty.  Worried about AC joint involvement .  Concern over length of needle ( nurse used recommended 1" needle)  into deltoid muscle.  Pt was given VIS - declined to take home.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint range of motion decreased, Neck pain
Clinical narrative: 5 hours post injection pt reports fits of crying, injection site pain, shoulder pain, neck pain, sternum pain, back pain.  ROM difficulty.  Pt was anxious prior to injection.  Pt seen next day with continued discomfort.  No obvious swelling redness.  Still c/o ROM difficulty.  Worried about AC joint involvement .  Concern over length of needle ( nurse used recommended 1" needle)  into deltoid muscle.  Pt was given VIS - declined to take home.
Age: 16.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: C-reactive protein increased, Glossodynia, Hepatic enzyme increased, Hypophagia, Nausea
Clinical narrative: Patient presented to the ER for 3-day history of nausea, vomiting and decreased oral intake.  Patient also endorses having a fever during this time up to 103F.  Patient states she has had a sore throat and sore tongue for the last day and is unsure if the rash is caused from the vomiting/gagging.  Patient says she received her flu shot and second dose of meningococcal about a week ago on December 30 and now has a rash on her left shoulder where she got the shots, as well as a mildly red non-itchy rash on her upper legs.  Patient denies CP, SOB, abdominal pain, increased urinary frequency, dysuria.
Age: 16.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Oropharyngeal pain, Pyrexia, Rash, Rash erythematous, Red blood cell sedimentation rate increased
Clinical narrative: Patient presented to the ER for 3-day history of nausea, vomiting and decreased oral intake.  Patient also endorses having a fever during this time up to 103F.  Patient states she has had a sore throat and sore tongue for the last day and is unsure if the rash is caused from the vomiting/gagging.  Patient says she received her flu shot and second dose of meningococcal about a week ago on December 30 and now has a rash on her left shoulder where she got the shots, as well as a mildly red non-itchy rash on her upper legs.  Patient denies CP, SOB, abdominal pain, increased urinary frequency, dysuria.
Age: 16.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Retching, Ultrasound abdomen normal, Ultrasound bladder normal, Ultrasound kidney normal, Vomiting
Clinical narrative: Patient presented to the ER for 3-day history of nausea, vomiting and decreased oral intake.  Patient also endorses having a fever during this time up to 103F.  Patient states she has had a sore throat and sore tongue for the last day and is unsure if the rash is caused from the vomiting/gagging.  Patient says she received her flu shot and second dose of meningococcal about a week ago on December 30 and now has a rash on her left shoulder where she got the shots, as well as a mildly red non-itchy rash on her upper legs.  Patient denies CP, SOB, abdominal pain, increased urinary frequency, dysuria.
Age: 16.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: White blood cell count increased
Clinical narrative: Patient presented to the ER for 3-day history of nausea, vomiting and decreased oral intake.  Patient also endorses having a fever during this time up to 103F.  Patient states she has had a sore throat and sore tongue for the last day and is unsure if the rash is caused from the vomiting/gagging.  Patient says she received her flu shot and second dose of meningococcal about a week ago on December 30 and now has a rash on her left shoulder where she got the shots, as well as a mildly red non-itchy rash on her upper legs.  Patient denies CP, SOB, abdominal pain, increased urinary frequency, dysuria.
Age: 1.58
Sex: M
Vaccine: HIBV, PNC20
Symptoms: Extra dose administered
Clinical narrative: These imms were given again instead of what should have been the DTaP & Hep A. Repeated out 15mo imms instead of giving the 18mo imms.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Headache, Malaise, Nausea
Clinical narrative: The patient stated that she was violently sick for about a week after her first COVID (Moderna) Vaccine. She was bothered by gastrointestinal upset, headaches, nausea, and dizziness.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reaction - just gave Kinrix when it was not the last dose of each series, Showed as Invalid, then the MA had them come back in 1 mo to get a DTaP when it should have been 6mo.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reaction - just gave this as a first dose and not the final as it's supposed to be.
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Mobility decreased, Periarthritis, Rotator cuff syndrome, X-ray limb
Clinical narrative: I developed adhesive capsulitis of the right shoulder after this vaccine with pain, impingement, decreased range of motion.  This developed slowly and became significant 4 weeks after the vaccine.  I was evaluated by an orthopedic specialist on 1/8/25 and received radiographs and a steroid injection.  He prescribed physical therapy.  Outcome is pending.
Age: 74.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: TENDER, WARM, KNOT THAT IS HARD BELOW INJECTION SITES
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: There was no adverse reaction. School just made mom aware. Unsure why this was not brought up to her before now by our office.
Age: 18.0
Sex: M
Vaccine: FLU3, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Feeling hot, Nausea, Nervousness, Syncope
Clinical narrative: Patient given vaccinations at 1238 and at 1241, patient reports feeling nauseous and hot,  and had vasovagal syncope for less than 5 seconds. Patient awake, alert, and jumpy, reports no other new concerns. No fever, no rash, and patient reports improvement in nausea.
Age: 41.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient has burning, pain, redness, itching, swelling at inject site. Patient is taking tylenol and benadryl to help with symptoms.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Pain in extremity
Clinical narrative: Patient reports he noted typical arm  soreness the day after the vaccine.  He now reports he has weakness and pain in his left shoulder that continues to bother him.  He reports he generalized weakness in the arm when he raises it.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse events, after vaccination was administered, it was realized the vaccine had expired
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Rheumatoid arthritis
Clinical narrative: new onset rheumatoid arthritis in an 83 yr old woman.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Tylenol  for pain,
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt received an adult dose of Hep B instead of the pediatric Hep B.  This dose was the 2nd dose in her 3 dose series.  Pt left appointment on good terms. No calls from patient after visit reporting any symptoms/adverse reactions.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Swelling and redness and pain at injection site and I?ll for a couple days. Long term chronic hives, still ongoing.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Muscular weakness
Clinical narrative: Patient reported to pharmacy on 1/10/25 that since the immunization on 10/8/24 she has experienced a dull, achy soreness in the left deltoid where immunization was given. Onset of symptoms occurred immediately upon injection and has not worsened or improved since.  Reports pain is located specifically in the muscle where immunization was given. She denies pain in the shoulder joint or any other areas of arm. Denies numbness or tingling, but does report the arm feels "weak." She denies any limitations to mobility in the shoulder, states pain is "not sharp, not burning" and that it is "just there, more annoying than anything else." In regards to location of the pain, she states it is in the muscle herself, "there is pin-point soreness on the exact spot the vaccine was given." If she rubs this area, it feels as if she is rubbing out a sore muscle. This "spot" is right in the middle of her arm, states the location is more than 3-finger widths below the shoulder. She reports her daughter is a pharmacist and informed her over the holidays she could have SIRVA. I asked her if she has seen a doctor for the pain and she has not. I encouraged her to see a doctor so can get an evaluation and diagnosis for a better understanding of what is going on. States is "very hard to get an appointment with her doctor for anything non-urgent." Informed her there are walk in hours she could also look into. She has an annual appointment with her PCP on 2/10/25 so plans to discuss this with them at the appointment. Pt aware we are submitting VAERS for her, she called to inform us of the current situation and plans to keep us updated with anything further.
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: We received an email to verify the clinical accuracy of this patient's vaccine history. Upon review, I realized she had already received one dose of Arexvy in 2023. I called the patient, and she did not even remember getting it before, but she said she is feeling fine with no side effects.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient given wrong dose due to age. Dosage given was for 5-11 yo; patient 4.5 years at administration.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult Covid vaccine (Spikevax) dose given to child instead of Moderna Covid 6m-11yrs. No adverse reactions noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient for MMRV following 7 days from expiration. Mother notified and patient will be revax in 4 weeks via mother's consent already obtained.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: pt was administered a 65 plus vaccine and they were only 63 no clinical adverse effects
Age: 1.0
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMR, PNC20, VARCEL
Symptoms: Abnormal behaviour, Computerised tomogram, Drooling, Electroencephalogram, Fatigue
Clinical narrative: REPORTS, 8-9PM NOT ACTING NORMAL, OBSERVED TWITCHING THEN DROWSY AND FATIGUED, AND STARE OFF INTO SPACE, T100.3f, THEN PROGRESSED TO DROOLING, SHAKING AND UNRESPONSIVE, TRANSFERRED TO ED, GIVEN MIDAZZ AND TOOK A WHILE TO STOP TWITCHING AND SHAKING, RECEIVED RECTAL TYLENOL IN ED. THEN ADMITTED TO HOSPITAL
Age: 1.0
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMR, PNC20, VARCEL
Symptoms: Muscle twitching, Somnolence, Staring, Tremor, Unresponsive to stimuli
Clinical narrative: REPORTS, 8-9PM NOT ACTING NORMAL, OBSERVED TWITCHING THEN DROWSY AND FATIGUED, AND STARE OFF INTO SPACE, T100.3f, THEN PROGRESSED TO DROOLING, SHAKING AND UNRESPONSIVE, TRANSFERRED TO ED, GIVEN MIDAZZ AND TOOK A WHILE TO STOP TWITCHING AND SHAKING, RECEIVED RECTAL TYLENOL IN ED. THEN ADMITTED TO HOSPITAL
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt returned to clinic with concern for redness and swelling to left arm. She believes it may be related to covid vaccination
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none the +65 age shot was given to someone 60yo
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Balance test, Blood test, Brain fog, Catheterisation cardiac
Clinical narrative: Starting in July 2022, became suddenly confused with dizziness and hearing deficit. Confusion and brain fog resolved months later but dizziness and hearing deficit persist. Chronic Nausea now present, starting early 2025.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Computerised tomogram, Confusional state, Dizziness, Endoscopy
Clinical narrative: Starting in July 2022, became suddenly confused with dizziness and hearing deficit. Confusion and brain fog resolved months later but dizziness and hearing deficit persist. Chronic Nausea now present, starting early 2025.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Laboratory test, Magnetic resonance imaging, Nausea
Clinical narrative: Starting in July 2022, became suddenly confused with dizziness and hearing deficit. Confusion and brain fog resolved months later but dizziness and hearing deficit persist. Chronic Nausea now present, starting early 2025.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 65+ vaccine given to a LTC pt that was only 55 years old  no clinical events occurred
Age: 69.0
Sex: M
Vaccine: PNC21
Symptoms: Arthralgia, Decreased appetite, Erythema, Fatigue, Headache
Clinical narrative: redness, swelling, painm fever, loss of appetite, irritablity, tired, headache, joint pain
Age: 69.0
Sex: M
Vaccine: PNC21
Symptoms: Irritability, Pain, Pyrexia, Swelling
Clinical narrative: redness, swelling, painm fever, loss of appetite, irritablity, tired, headache, joint pain
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Received pediatric Hep B vaccine instead of Helisav-B
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Patient received COVID 6 m-11 years injection as error. Patient is 19 years of age and should of received the 12 years +. Provider and patient notified. Patient will return another time to receive full dose patient had no adverse reaction.  Moderna COVID-19 2024-2025 formula 0.25 mL single dose NDC 80777-291-80 LOT 3044186 EXP 06-21-2025
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adr mentioned, he came in for another RSV vaccine and we discovered he'd already had 2.
Age: 58.0
Sex: F
Vaccine: HEPAB, PNC21
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain, swelling and redness at and below the site of injection. also complains of dizziness.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient received PROQUAD vaccine dose before age corresponded, she is 3 years and 7 months old.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Syncope, Vomiting
Clinical narrative: The  patient fainted , turned pail and vomited.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient called stating she got vaccine and had normal arm pain for 2-3 days after and then it went away for about 5-7 days then the pain came back and now she can't lift her arm without having pain. Questioned her on whether or not she had any other injury to arm (bang against something etc). Patient states that didn't happen. Counseled to have PCP or Urgent care evaluate right away to make sure something else hasn't happened to her arm in the meantime.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythematous and edematous area larger than a quarter-size on bilateral legs noted by provider immediately after injections.
Age: 13.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Disorientation, Loss of consciousness, Nervousness, Syncope
Clinical narrative: Patient received start over vaccinations including Tdap, IPV, Hep. A, Hep. B, MMR, Varicella, and MCV4. Patient was nervous while receiving vaccines, this nurse ensured to remind patient to take deep breaths and relax in between each shot. Once completing the vaccines, patient fainted. This nurse called for help and immediately got an ice pack and water and put the ice pack behind patients neck. Patient woke up immediately and was disoriented for a minute but then was able to recite his full name, birthday and where he was. Patient was then given a granola bar and water to drink. When asked, patients parent stated that patient had not eaten any food today. Initial vitals were BP 89/64 P 49 02 99% room air. Vitals rechecked after 15 minutes, were as follows. BP 138/83 P63 02 99% room air. Parents were advised to take patient to hospital to have patient checked out. Parents agreed to take patient. Both mother and father were present. Discharge papers given to patients parents.
Age: 64.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient arrived to clinic for flu vaccine. Patient is 64 years old with insurance and history of breast cancer/lumpectomy. Verified patient name and DOB prior to vaccine administration. Discussed with patient additional recommendation for pneumonia vaccine as patient last had Pneumovax 23 in 2019 (verified by this provider). Patient consented to this vaccine as well. Documented both vaccines on paper form prior to administration. Discovered after patient left while inputting vaccines into medical record that patient is 64 years old not 65. Notified supervisor and attempted to make patient contact but voicemail box was full. Made incident report per company guidance and submitted VAERS report. Was later able to contact patient and notified of error. Patient did not have any concerns regarding vaccine error.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Amnesia, Blood pressure increased, Condition aggravated, Confusional state, Hypertension
Clinical narrative: fever, confusion, blood pressure higher than normal, memory loss/confusion    time course: continuing
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Laboratory test, Pyrexia
Clinical narrative: fever, confusion, blood pressure higher than normal, memory loss/confusion    time course: continuing
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cough, Pyrexia, Unresponsive to stimuli
Clinical narrative: PER PATIENT'S MOTHER ON 01/05/2025 PATIENT WAS HAVING A FEVER AND COUGH, MOM GAVE TYLENOL TO THE PATIENT AND NEXT DAY PATIENT WAS UNRESPONSIVE.
Age: 77.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Seizure
Clinical narrative: Pt states she has a severe headache/seizure 12 hrs post administration
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood pressure decreased, Fatigue, Headache, Nausea, Pallor
Clinical narrative: Vision blurrines, Fatigue, Tremor, Paller, Nausea, Headache. BP lower than when he originally came in at 9 Started around 12:00 came to office at 12:15 monitored SPo2 and HR and BP. BP did drop from 109/66 to 95/64, gave benadryl and tylenol
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Tremor, Vision blurred
Clinical narrative: Vision blurrines, Fatigue, Tremor, Paller, Nausea, Headache. BP lower than when he originally came in at 9 Started around 12:00 came to office at 12:15 monitored SPo2 and HR and BP. BP did drop from 109/66 to 95/64, gave benadryl and tylenol
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid function disorder, Facial paralysis, Fatigue, Headache, Hypoaesthesia oral
Clinical narrative: 12/15/2024 - Started with pain on right side of the neck from back of the right ear to right neck and to shoulders including right arm injection site. Dull pain causing loss of sleep.12/26/2024 - Saw Dr for annual check-up and was experiencing Benign paroxysmal positional vertigo from the right ear. 1/3/2025 - experience increased pain on right side of the head behind the ear, under right jaw, through back right side of the head and shoulders. Continued all weekend up to 1/7/2025. Noticed right eye drooping a bit during the weekend. 1/7/2025 - woke up and had trouble brushing teeth, unable to control right side of the lips. Eyes are not in sync and right eye is drooping more. Checked-in to ER at 1030AM. ER Physician ordered MRI and checked for stroke. MRI results ruled out stroke. ER Physician diagnosed Bell's Palsy caused by virus. Prescribed MethylPrednisolone 4mg therapy pak, vaIACYclovir 1g 1000mg tab every 8 hours for 7 days.  1/08/2025 - 1/12/2025 Ball's Palsy symptoms have progressed. Right eyelid weak, unable to fully close and having trouble blinking. Eyes are watery and unable to focus, get blinded by outside light, unable to drive and gets really tired.  Unable to eat on right side of the mouth due to inner cheek muscles unusable, food getting stuck. Unable to drink from glass or cup, had to use straw with fingers to seal lips to sip liquids. Mid-line of upper and lower lips feel numb/tingling. Right side of tongue feels different. Experiencing pain on right side of the head to include behind the ear, under the ear by the jaw, back of the neck down to right shoulder. Unable to have continuous sleep. 1/13/2025 - Office visit with Dr  Advised Dr of the above health problem and timeline. Dr confirmed that it is Bell's Palsy. Recommend rest and to complete prescribed medication by ER. Scheduled Follow-up in two weeks with him.  1/14/2025 - Woke up at 3AM with extreme pain on right side of head specifically, behind the right ear, right just below cheek bone, under the right eye, behind the right neck and to right shoulder. It feels like pain from a dental work done on the right side of my face. Stayed in bed taking naps until 10AM. Pain subsided then.  Previous Moderna Covid 19 vaccinations (total 6 shots) didn't have any adverse reactions. First time vaccinated with Pfizer Covid booster on 12/5/2024 -Submitted this report for possible Bell's Palsy side effect from Pfizer Covid Booster.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired driving ability, Injection site pain, Lacrimation increased, Magnetic resonance imaging head normal, Neck pain
Clinical narrative: 12/15/2024 - Started with pain on right side of the neck from back of the right ear to right neck and to shoulders including right arm injection site. Dull pain causing loss of sleep.12/26/2024 - Saw Dr for annual check-up and was experiencing Benign paroxysmal positional vertigo from the right ear. 1/3/2025 - experience increased pain on right side of the head behind the ear, under right jaw, through back right side of the head and shoulders. Continued all weekend up to 1/7/2025. Noticed right eye drooping a bit during the weekend. 1/7/2025 - woke up and had trouble brushing teeth, unable to control right side of the lips. Eyes are not in sync and right eye is drooping more. Checked-in to ER at 1030AM. ER Physician ordered MRI and checked for stroke. MRI results ruled out stroke. ER Physician diagnosed Bell's Palsy caused by virus. Prescribed MethylPrednisolone 4mg therapy pak, vaIACYclovir 1g 1000mg tab every 8 hours for 7 days.  1/08/2025 - 1/12/2025 Ball's Palsy symptoms have progressed. Right eyelid weak, unable to fully close and having trouble blinking. Eyes are watery and unable to focus, get blinded by outside light, unable to drive and gets really tired.  Unable to eat on right side of the mouth due to inner cheek muscles unusable, food getting stuck. Unable to drink from glass or cup, had to use straw with fingers to seal lips to sip liquids. Mid-line of upper and lower lips feel numb/tingling. Right side of tongue feels different. Experiencing pain on right side of the head to include behind the ear, under the ear by the jaw, back of the neck down to right shoulder. Unable to have continuous sleep. 1/13/2025 - Office visit with Dr  Advised Dr of the above health problem and timeline. Dr confirmed that it is Bell's Palsy. Recommend rest and to complete prescribed medication by ER. Scheduled Follow-up in two weeks with him.  1/14/2025 - Woke up at 3AM with extreme pain on right side of head specifically, behind the right ear, right just below cheek bone, under the right eye, behind the right neck and to right shoulder. It feels like pain from a dental work done on the right side of my face. Stayed in bed taking naps until 10AM. Pain subsided then.  Previous Moderna Covid 19 vaccinations (total 6 shots) didn't have any adverse reactions. First time vaccinated with Pfizer Covid booster on 12/5/2024 -Submitted this report for possible Bell's Palsy side effect from Pfizer Covid Booster.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Photophobia, Sleep disorder, Tongue discomfort, Vision blurred
Clinical narrative: 12/15/2024 - Started with pain on right side of the neck from back of the right ear to right neck and to shoulders including right arm injection site. Dull pain causing loss of sleep.12/26/2024 - Saw Dr for annual check-up and was experiencing Benign paroxysmal positional vertigo from the right ear. 1/3/2025 - experience increased pain on right side of the head behind the ear, under right jaw, through back right side of the head and shoulders. Continued all weekend up to 1/7/2025. Noticed right eye drooping a bit during the weekend. 1/7/2025 - woke up and had trouble brushing teeth, unable to control right side of the lips. Eyes are not in sync and right eye is drooping more. Checked-in to ER at 1030AM. ER Physician ordered MRI and checked for stroke. MRI results ruled out stroke. ER Physician diagnosed Bell's Palsy caused by virus. Prescribed MethylPrednisolone 4mg therapy pak, vaIACYclovir 1g 1000mg tab every 8 hours for 7 days.  1/08/2025 - 1/12/2025 Ball's Palsy symptoms have progressed. Right eyelid weak, unable to fully close and having trouble blinking. Eyes are watery and unable to focus, get blinded by outside light, unable to drive and gets really tired.  Unable to eat on right side of the mouth due to inner cheek muscles unusable, food getting stuck. Unable to drink from glass or cup, had to use straw with fingers to seal lips to sip liquids. Mid-line of upper and lower lips feel numb/tingling. Right side of tongue feels different. Experiencing pain on right side of the head to include behind the ear, under the ear by the jaw, back of the neck down to right shoulder. Unable to have continuous sleep. 1/13/2025 - Office visit with Dr  Advised Dr of the above health problem and timeline. Dr confirmed that it is Bell's Palsy. Recommend rest and to complete prescribed medication by ER. Scheduled Follow-up in two weeks with him.  1/14/2025 - Woke up at 3AM with extreme pain on right side of head specifically, behind the right ear, right just below cheek bone, under the right eye, behind the right neck and to right shoulder. It feels like pain from a dental work done on the right side of my face. Stayed in bed taking naps until 10AM. Pain subsided then.  Previous Moderna Covid 19 vaccinations (total 6 shots) didn't have any adverse reactions. First time vaccinated with Pfizer Covid booster on 12/5/2024 -Submitted this report for possible Bell's Palsy side effect from Pfizer Covid Booster.
Age: 0.92
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: There were no physical symptoms.  The vaccine had expired at the end of December 2024 and was not removed from the refrigerator.  The RN administering failed to check the expiration date prior to administration.  software caught the error during documentation of the visit.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: No adverse event
Clinical narrative: no adverse events noted when patient was contacted
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Pain, Shoulder injury related to vaccine administration
Clinical narrative: Had left deltoid pain that began within 24 hours of vaccine and is still present 8 weeks later. She has decreased range of motion, pain with shoulder abduction. Suspect SIRVA.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: DEATH (death), outcome "fatal", described as "passed away". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500007761 Same event/vaccine, different patient;; Reported Cause(s) of Death: Unknown cause of death