chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Tendonitis
Clinical narrative: chronic tendonitis on my whole left arm and left hand to intensify, from my shoulder to my fingers; The pain was so bad I had to go to the emergency room. The pain lasted for months, my left hand still hurts.; my left hand still hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), 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 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: TENDONITIS (non-serious), outcome "not recovered", described as "chronic tendonitis on my whole left arm and left hand to intensify, from my shoulder to my fingers"; PAIN (non-serious), outcome "not recovered", described as "The pain was so bad I had to go to the emergency room. The pain lasted for months, my left hand still hurts."; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "my left hand still hurts". The event "the pain was so bad i had to go to the emergency room. the pain lasted for months, my left hand still hurts." required emergency room visit.   Additional information: the fifth dose on 14Nov2022 caused all of patient's chronic tendonitis on the whole left arm and left hand to intensify, from  shoulder to fingers. The pain was so bad patient had to go to the emergency room. The pain lasted for months, left hand still hurts. Patient was afraid to get the new booster, can't use the right arm, because had chronic tendonitis in that shoulder and hand also.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Discomfort, Feeling cold, Tremor
Clinical narrative: feeling cold; felt very uncomfortable; go to bed where he was shaking; Initial information received on 17-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 82 years old male patient who experienced go to bed where he was shaking, feeling cold and felt very uncomfortable after receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Sep-2023, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine Suspension for injection in pre-filled syringe lot NDC 49281-0123-65 via intramuscular route in unknown administration site for prophylactic vaccination (immunization).  On 11-SEP-2023 the patient developed go to bed where he was shaking (chills), feeling cold and felt very uncomfortable (discomfort) on the same day following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, Following a Fluzone High Dose injection on Sep 11th, 2023, the patient felt very uncomfortable, was cold and had to go to bed where he was shaking due to feeling cold. Symptoms disappeared the next day after one night in bed.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events go to bed where he was shaking, feeling cold, felt very uncomfortable.  At time of reporting, the outcome was Recovered / Resolved on 12-Sep-2023 for the event go to bed where he was shaking, feeling cold and felt very uncomfortable.
Sex: U
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: cold; Initial information received on 15-Sep-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of an unknown age and gender who experienced cold after receiving Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, expiry date, formulation and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed cold (nasopharyngitis) (unknown latency). It was unknown if the patient experienced any additional symptoms/events.  Reportedly: we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: it works for me. Yes I know about the flu shots. Same here, I got one cold after another taking my last one in 89. They became mandatory   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: extra dose of FLUZONE HD QIV administered to a patient with no adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown age and demographics who was administered an extra dose of Influenza Quadrival A-B High Dose HV vaccine [Fluzone high-dose quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an extra, unknown dose of suspect Influenza Quadrival A-B High dose HV vaccine (strength, formulation, lot number and expiry: not reported) via unknown route in unknown administration site for influenza (extra dose administered) (latency: same day). Information on the batch number was requested.  No lab data was provided.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: excursion lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 C (with no reported adverse event); vaccine was deemed not suitable as of today and they just realized that the same vaccine had been administered (with no reported adverse event); Initial information received on 15-Sep-2023 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 6-month-old female patient and is reported vaccine HIB (PRP/T) vaccine [ACT-HIB] who experienced excursion lasted for 19 hours and the thermometer showed the lowest cold reading as negative 2.2 c was deemed not suitable as of today and they just realized that the same vaccine had been administered (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), pertussis vaccine acellular 3-component, polio vaccine inact 3V (VERO), tetanus vaccine toxoid (Pediarix); and pneumococcal vaccine conj 7V (CRM197) (Prevnar) for Prophylactic vaccination (immunization).  On 06-Sep-2023, the patient received a dose 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot UJ834AA expiry date: 23-Feb-2024 via intramuscular route in the thigh not specified for Immunization and excursion lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 c (with no reported adverse event) (product storage error).   On 06-SEP-2023 vaccine was deemed not suitable as of today and they just realized that the same vaccine had been administered (with no reported adverse event) (poor quality product administered) on the same day following the administration of HIB (PRP/T) Vaccine.  Reported that they had a temperature excursion for ACTHIB on 30Aug2023. They had a hurricane coming and they didn't have an extra fridge to transfer the vaccine into, so someone packed the vaccines in the refrigerator with ice packs, however the ice packs were placed right beside the thermometer, so the reading went below zero, although none of the vaccines were actually frozen. The excursion lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 C.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TDAP
Symptoms: Mast cell activation syndrome
Clinical narrative: mast cell activation syndrome; Initial information received on 16-Sep-2023 regarding an unsolicited valid  serious case received from a patient.  This case is linked to case 2023SA286262(CLUSTER).  This case involves female patient of an unknown gender who experienced mast cell activation syndrome after receiving diphtheria-2/tetanus/5 Ac Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Food allergy with allergies are worse--she is more reactive in general than she was 20 years ago..  Concomitant Medications Included Diphenhydramine Hydrochloride (Benadryl [Diphenhydramine Hydrochloride]).  On an unknown date, the patient received a unknown dose of suspect diphtheria-2/tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization. Information on the batch number requested.  On an unknown date the patient developed mast cell activation syndrome (unknown latency). This event was assessed as medically significant.  Reported: She recently was able to successfully take the shingles vaccine co-administered with Benadryl. She stated that she has mast cell activation syndrome.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.; Sender's Comments: Sanofi company comment for information received on 21-Sep-2023: This case involves female patient of an unknown gender who experienced mast cell activation syndrome after receiving diphtheria-2/tetanus/5 Ac Pertussis Vaccine [Adacel]. The patient had current condition included Food allergy which could be confounding factor. Further information regarding tolerance, medical or family history and Concomitant medication excluding alternative etiologies for the reported event are needed to fully assess this case. Based up on the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: inadvertent administration of an expired dose of pentacel to a patient with no reported adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 13-month-old female patient who was inadvertently administered an expired dose of pentacel with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 19-Sep-2023, the patient received total 0.5 ml of suspect diphtheria/tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine, Suspension for injection dose 3 (lot UJ736AAA and expiry 18-Sep-23) via intramuscular route in right leg for prophylactic vaccination (strength, expiry date: unknown), inadvertent administration of an expired dose of pentacel to a patient with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.   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: 40.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: gave with the wrong sized needle, so it ended up being injected to the SQ area instead of IM with no reported adverse event; Initial information was received on 19-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 40 years old adult patient of unknown gender to whom influenza quadrival A-B vaccine [Fluzone QIV] was given with the wrong sized needle, so it ended up being injected to the sq area instead of im 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 an unknown dose (once) of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot number, expiry date: unknown) (Strength: standard) via subcutaneous route in unknown administration site for Immunization and was given wrong sized needle, so it ended up being injected to the sq area instead of im with no reported adverse event (incorrect route of product administration) (Latency: same day). The information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 65.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 2 patients were administered the fluzone quadrivalent vaccine rather than the fluzone high-dose quadrivalent vaccine with no reported adverse event; Initial information was received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA288625.  This case involves 65 years old male patient who experienced 2 patients were administered the influenza quadrival a-b vaccine [Fluzone QUADRIVALENT] rather than the influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] 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 a unknown dose of suspect influenza quadrival a-b high dose hv vaccine and influenza quadrival a-b vaccine (Suspension for injection) (strength, lot number, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on batch number was requested.  On an unknown date the 2 patients were administered the fluzone quadrivalent vaccine rather than the fluzone high-dose quadrivalent vaccine with no reported adverse event (wrong product administered) (latency : same day) following the administration of influenza quadrival a-b high dose hv vaccine and influenza quadrival a-b vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 2 patients were administered the fluzone quadrivalent vaccine rather than the fluzone high-dose quadrivalent vaccine with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: inadvertent administration of an expired product to a patient with no reported adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 5-month-old female patient who had inadvertent administration of an expired product diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)]to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine 13V (Pneumococcal 13 Valent Vaccine) for Prophylactic vaccination; and rotavirus vaccine for Prophylactic vaccination.  On 19-Sep-2023, the patient received a dose 1 of 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength: unknown) (lot: UJ737AAA, expiry date: 18-Sep-2023) via intramuscular route in the right thigh for Immunization and inadvertent administration of an expired product to a patient with no reported adverse event (expired product administered) (latency: same day).  Action taken with diphtheria, tetanus, AC pertussis, IPV and HIB vaccine (Pentacel (VERO)) was not applicable.  Outcome: unknown.   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: 49.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: fluzone high dose quadrivalent is given to a patient under the age 65 with no reported adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 49 years old female patient to whom fluzone high dose quadrivalent was given patient under the age 65 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 tozinameran (comirnaty) for COVID-19 immunisation.  On 19-Sep-2023, the patient received suspect influenza quadrival A-B high dose HV vaccine lot U8044AB via intramuscular route in the left deltoid for prophylactic vaccination (strength, dose and expiry date: unknown), given to a patient under the age 65 with no reported adverse event (product administered to patient of inappropriate age) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event product administered to patient of inappropriate age.  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: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: given an expired ACT-HIB to a patient  (with no reported adverse event); Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient who was  given an expired HIB (PRP/T) vaccine [ACT-HIB] (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, tetanus vaccine toxoid (Daptacel); and pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine) for prophylactic vaccination (Immunisation).  On 18-Sep-2023, the patient received a dose 4 dose 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot UJ798AB expiry date: 11-sep-2023 via intramuscular route in Right Quad Muscle for immunization and given an expired act-hib to a patient  (with no reported adverse event) (expired product administered) on the same day following the administration of HIB (PRP/T) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event given an expired act-hib to a patient  (with no reported adverse event).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 3.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of vaccine given to a patient with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 3 years old male patient where expired dose of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] given to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 20-Sep-2023, the patient received 0.5 ml TOTAL dose 1 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (lot UJ682AA and expiration date- 16-Sep-2023) via intramuscular route in the left thigh (strength: not provided) for Immunisation (expired product administered) (latency- same day).  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: given the ACTHIB expired with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown demographics who was given the HIB (PRP/T) vaccine [ACT-HIB] expired 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 a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection dose, strength: not reported lot UJ798AB expiry date: 11-Sep-2023 via unknown route in unknown administration site for Immunization and given the acthib expired with no reported adverse event (expired product administered) on the same day following the administration of HIB (PRP/T) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event given the acthib expired with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 85.0
Sex: F
Vaccine: FLUA4, RSV, RSV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Second RSV vaccine administered in error. No change in patient's medical state reported thus far.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, No adverse event
Clinical narrative: no adverse reaction, but patient was determined to have low varicella zoster titers and should have received the varicella vaccine, not the Shingrix
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head injury
Clinical narrative: patient received vaccine and then went shopping and when she got to her car she felt dizzy and then hit her head. she said she went to the er  but patient is fine and they did not treat her
Age: 35.0
Sex: M
Vaccine: COVID19, FLUR4
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Loss of consciousness, Seizure
Clinical narrative: Patient received both comirnaty covid and flublok quad.  After receiving the vaccine he felt light headed, dizzy, sweaty and passed out or had a seizure.  The EMT was called.  Patient did come too on his own but EMT was called to check him out.  He was experiencing low blood pressure and EMT choose to take him to the hospital.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: I have a constant low grade constant hum in my ears. I am assuming its Tinnitus.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 57.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Nausea
Clinical narrative: Extreme pain in right  arm going from shoulder to hand. It intensified over several hours until it was almost unbearable. Nausea. Headache. Fatigue.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Trumenba given to patient at age 11 instead of Menquadfi.  Patient/parent notified and was scheduled to return for vaccination of Menquadfi.  No adverse effects to patient.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye movement disorder, Flushing, Hyperhidrosis, Hypoglycaemia, Unresponsive to stimuli
Clinical narrative: FLUSHING, SWEATING, LACK OF RESPONSE TO QUESTIONS, EYE ROLLING. RESPONDED TO ICE PACKS ON THE BACK OF THE NECK. UPON REVIEW WAS ALSO HYPOGLYCEMIC. NON-DIABETIC.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 1.42
Sex: M
Vaccine: PNC13
Symptoms: Blood gases normal, Cardioversion, Condition aggravated, Echocardiogram normal, Electrocardiogram
Clinical narrative: 4 days after vaccination, previously controlled SVT returned in morning 9/23. Treatment was refractory to control with escalation with his current anti-arrhythmic class of medication. Control returned after addition of 2nd anti-arrhythmic class of medication.  Control obtained 2100 on 9/23.
Age: 1.42
Sex: M
Vaccine: PNC13
Symptoms: Full blood count normal, Metabolic function test normal, Supraventricular tachycardia
Clinical narrative: 4 days after vaccination, previously controlled SVT returned in morning 9/23. Treatment was refractory to control with escalation with his current anti-arrhythmic class of medication. Control returned after addition of 2nd anti-arrhythmic class of medication.  Control obtained 2100 on 9/23.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 88.0
Sex: F
Vaccine: RSV
Symptoms: Oxygen saturation decreased
Clinical narrative: Patient had low oxygen and later had to go to the emergency room.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Blood pressure increased, Chills, Headache, Heart rate irregular, Hypertension
Clinical narrative: Approximately eleven hours after vaccination patient reports extreme chills, increased blood pressure, irregular heart rate, and headache.  This reaction prompted a call to EMS.  Emergency responders medically evaluated the patient and confirmed hypertensive status and irregular heartbeat suggesting patient follow up with her cardiologist.  Patient is now recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: After receiving a booster vaccine,  I developed Tinnitus in my right ear.  I've been tested for other possibilities that would cause it and there is nothing else that coincides with the onset of Tinnitus.
Age: 60.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Pain
Clinical narrative: Patient's daughter called day after vaccines to report that patient was experiencing head to toe to pain like she had never had before. She also got a flu shot elsewhere before getting Abrysvo and Spikevax from us.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, Blood urine present, Chromaturia
Clinical narrative: Blood in urine and  slight back pain on left side (kidney area?). Noticed change in urine around 7 pm on 9/24/23. On morning of 9/25/23 urine extremely dark brown, then gradually during the day it lighten up to pink/light red.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nasal congestion, Oropharyngeal pain, Respiratory tract congestion, Secretion discharge
Clinical narrative: Severe ongoing headache for 4 days, sore throat, congestion, copious mucous, lethargy, developed sinus infection due to severe nasal congestion.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Severe ongoing headache for 4 days, sore throat, congestion, copious mucous, lethargy, developed sinus infection due to severe nasal congestion.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 67.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: itching, redness, warm to touch
Age: 67.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: itching, redness, warm to touch
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Dyspnoea, Erythema, Pharyngeal swelling, Swelling face
Clinical narrative: Swelling of throat and face Shortening of breath Dizziness/feeling of going to pass out Red face
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Blood glucose increased, Vaccine positive rechallenge
Clinical narrative: Patient experience blood sugar reading  over 500 for several days after receiving the vaccination.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 50.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Syncope
Clinical narrative: fainted next day
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Mobility decreased, Pain, Pyrexia
Clinical narrative: 1st night: achy, feverish , slight headache 2nd day: intense headache  ( no medications would quell ) , multiple vomiting, fever, aches  ( basically bedridden ) lethargic 3rd day: achy,  mild headache
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 1st night: achy, feverish , slight headache 2nd day: intense headache  ( no medications would quell ) , multiple vomiting, fever, aches  ( basically bedridden ) lethargic 3rd day: achy,  mild headache
Age: 77.0
Sex: M
Vaccine: FLUA4, RSV
Symptoms: Chills, Diarrhoea, Insomnia, Nausea, Pain in extremity
Clinical narrative: Chills, Fever, Nausea, Diarrhea, Insomnia, Pain and Swelling in both arms.
Age: 77.0
Sex: M
Vaccine: FLUA4, RSV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Chills, Fever, Nausea, Diarrhea, Insomnia, Pain and Swelling in both arms.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Increased appetite
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dehydration, Dizziness, Electrocardiogram, Hyperhidrosis
Clinical narrative: Arm swelled up at injection site. Flu like symptoms for next few days. Eventually would up being taken by ambulance to ER with suffering from dizziness, vomiting, sever diaphoresis.  Found to have sudden onset vertigo and severe dehydration. Still feeling some mild flu like symptoms?.but do not have the flu.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site swelling, Laboratory test, Scan with contrast, Vertigo
Clinical narrative: Arm swelled up at injection site. Flu like symptoms for next few days. Eventually would up being taken by ambulance to ER with suffering from dizziness, vomiting, sever diaphoresis.  Found to have sudden onset vertigo and severe dehydration. Still feeling some mild flu like symptoms?.but do not have the flu.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Arm swelled up at injection site. Flu like symptoms for next few days. Eventually would up being taken by ambulance to ER with suffering from dizziness, vomiting, sever diaphoresis.  Found to have sudden onset vertigo and severe dehydration. Still feeling some mild flu like symptoms?.but do not have the flu.
Age: 86.0
Sex: F
Vaccine: FLUA4
Symptoms: Back pain, Gait inability, Hyperhidrosis, Malaise
Clinical narrative: Patient felt fine immediately after receiving shot and say it was painless but reported needing help while shopping right after in store since she experienced sharp back pain, inability to walk, and sweating and overall sudden unwell feeling
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm was swelling, hot to the touch, and red
Age: 87.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient states arm hurts and hard to lift. Recommended waiting and if gets worse to talk to Doctor. Did recommend in separate arms at time of administration but patient insisted wanted one sore arm and not two. Did say would be more sore.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Electrocardiogram repolarisation abnormality, Malaise, Pallor
Clinical narrative: At approximately 1242 PM administered MenQuadfi into Right deltoid. Patient was alert and oriented at time of administration. Approximately 30-60 seconds after administration patient states he was not feeling well and became unresponsive, pale, never lost a pulse, patient regained consciousness, reported still not feeling well. Patient mother at bedside, EMS contacted at 1245 PM, paramedics arrived shortly after. Obtained Vitals signs initially Temp- 98.4, O2 98%, heart rate 64. After EMS arrived Blood pressure stable 122/75, heart rate 55-64, O2 98%. ECG performed by EMS who recommended patient be transported to "ER due to early repolarization of ST segments." Parent and patient declined recommendation. Patient walked out of clinic alert and oriented, stable with mother and states " feeling much better".   Patient and mother both declined ER visit for further evaluation and states that they will definitely go to ER if any concerns arise hereon after.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: large redness area around injection site, itchy, warm
Age: 81.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache
Clinical narrative: Headache for three days
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient received Afluria on 9/16/23. On 9/25/23 patient contacted the pharmacy complaining of arm soreness and mild shooting pain when exercising. Contacted her PCP Dr. to inform office about the arm soreness and pain and spoke with representative. Patient has not tried any treatments.
Age: 14.0
Sex: F
Vaccine: IPV
Symptoms: Headache, Pain, Pain in extremity, Paraesthesia, Photosensitivity reaction
Clinical narrative: 14 Y old female presents to clinic with grandmother who is legal guardian. Patient reports she recieved on 09/18/23 she recieved the polio vaccine at her pediatrician office. Patient reports following the vaccine she had some soreness in her arm a couple hours after the vaccine. Reports she woke up early Tuesday 09/19/23 morning with body aches all over. Reports she was having some photosensitivity and headache yesterday as well. Reports photosensitivity resolved. Reports today the soreness has resolved "other places but her legs still feel sore and achy". Reports she still has a headache but has been taking OTC medications for the headache that have been helping. Reports she had a temperature 99.8 at home last night. Denies any changes in her skin at the site or anywhere ese. Denies beginning any new medications. Reports full ROM of of arms and legs. Reports overall fatigue. Denies numbness. Reports "my legs were tingly this morning when I first got out of bed but they are not anymore".
Age: 14.0
Sex: F
Vaccine: IPV
Symptoms: SARS-CoV-2 test negative, Urine analysis
Clinical narrative: 14 Y old female presents to clinic with grandmother who is legal guardian. Patient reports she recieved on 09/18/23 she recieved the polio vaccine at her pediatrician office. Patient reports following the vaccine she had some soreness in her arm a couple hours after the vaccine. Reports she woke up early Tuesday 09/19/23 morning with body aches all over. Reports she was having some photosensitivity and headache yesterday as well. Reports photosensitivity resolved. Reports today the soreness has resolved "other places but her legs still feel sore and achy". Reports she still has a headache but has been taking OTC medications for the headache that have been helping. Reports she had a temperature 99.8 at home last night. Denies any changes in her skin at the site or anywhere ese. Denies beginning any new medications. Reports full ROM of of arms and legs. Reports overall fatigue. Denies numbness. Reports "my legs were tingly this morning when I first got out of bed but they are not anymore".
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, PNC13
Symptoms: Feeding intolerance, Irritability, Pyrexia, Rash
Clinical narrative: Rash started on 9/24/2023. Rash covering entire body including palms.  Baby had increased fussiness and feeding intolerance. Had expected fever for 3 days after  vaccination. Fever had resolved as of 9/23/2023. Mom noted that sibling who is now 5 had similar reaction to 1 year old vaccines
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain, Paraesthesia, Vomiting
Clinical narrative: The morning after the vaccine I experienced extreme nausea, diarrhea, aches, pains, scalp tingling. Was not able to keep food down for 9 hours.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Myalgia, Oropharyngeal pain
Clinical narrative: The day after I received the shot, I had the following symptoms:  1. Redness and large swelling at the injection site  2. A runny nose and sore throat 3. Fatigue and muscle pain
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Rhinorrhoea
Clinical narrative: The day after I received the shot, I had the following symptoms:  1. Redness and large swelling at the injection site  2. A runny nose and sore throat 3. Fatigue and muscle pain
Age: 64.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Vaccination site oedema, Vaccination site pain
Clinical narrative: Soreness starting 24 hrs after vaccination, duration of soreness approximately 36 hrs. Redness, approximately 4 cm x 6 cm area around vaccinated area, appearing about 36 hrs after vaccination, redness beginning to fade after 24 hrs, but still visible.
Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Back pain, Chest pain, Pain
Clinical narrative: pt and daughter returned to pharmacy approx 15-20 minutes after admin of Fluad, Pt was reporting she was having chest pain that was radiating to back. She did not believe it to be related to Fluad admin.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: Pharmacist intentionally gave 2 shots of Comirnaty instead of flu and Comirnaty, pharmacist did call CDC and Pfizer company for further recommendations. Pharmacist did observe for 15 minutes with no adverse events reported. Pharmacist did answer questions/concerns to the patient and suggest patient to monitor adverse events and self- report to pharmacist/MD for follow up
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal stiffness, Neck pain, Posture abnormal, Product administered at inappropriate site
Clinical narrative: Vaccine was given too high on the shoulder.  It was given only 1 finger breath below the acromion process.  Soon after (less than one hour) the injection was given, I (the patient) began having pain in the shoulder above the injection site and into the neck. I also began having a stiff neck with decreased ability to turn my head to the left and slightly decreased ability to turn my head to the right.  The next day (9/22/2023), I called the office to report the problem and suggested that a VAERS should be filled out, but was told that it was not necessary as I did not have any redness or swelling at the injection site. I was also told I could be seen if I wanted the site to be checked for swelling or redness, but since there was not any, I chose not to drive the 11 miles to the office.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dry skin, Erythema, Feeling hot, Pain of skin, Paraesthesia
Clinical narrative: This was the 23-24 new vaccine.  I had only had moderna b4, including the bivalent one in Sept. 2022.  I also had the flu vaccine in the same arm on same day.  Today at work I had skin incident that lasted about 30 mins.  Started in my face and then ears, neck, arms and finally legs.  Felt hot and dry, painful and tingling.  My skin was visibly red and swollen.  It resolved without intervention bit was unnerving.  Hope it doesn't come back.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin swelling
Clinical narrative: This was the 23-24 new vaccine.  I had only had moderna b4, including the bivalent one in Sept. 2022.  I also had the flu vaccine in the same arm on same day.  Today at work I had skin incident that lasted about 30 mins.  Started in my face and then ears, neck, arms and finally legs.  Felt hot and dry, painful and tingling.  My skin was visibly red and swollen.  It resolved without intervention bit was unnerving.  Hope it doesn't come back.