chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19, FLUX, UNK
Symptoms: Chills, Feeling hot, Hangover, Nausea
Clinical narrative: nausea; chills; feeling hot; Feeling like she has a hangover; Initial information received on 04-Nov-2023 regarding an unsolicited valid non-serious case received from a Patient. This was a courtesy case received from regulatory authority.  This case involves a 48 years old female patient (86.2 kg) who experienced nausea, chills, feeling hot and feeling like she has a hangover after receiving Influenza vaccine, Pfizer biontech Covid-19 vaccine and while treated with treprostinil diolamine [Orenitram].  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 Pulmonary arterial hypertension.  Concomitant medications included ondansetron hydrochloride, riociguat (adempas); lidocaine; fluoxetine, furosemide, loperamide hydrochloride, simeticone (imodium multi symptom relief); famotidine (pepcid); tramadol hydrochloride (tramadol hcl); levothyroxine sodium (synthroid); fluticasone propionate (flonase allergy relief); loratadine, gabapentin, lamotrigine, calcium carbonate (tums); paracetamol (tylenol); salbutamol sulfate (albuterol sulfate); macitentan (opsumit); and diphenhydramine hydrochloride (benadryl).  On 18-Oct-2023, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, route, formulation, strength and expiration date: not provided) for Immunisation.  On 03-Nov-2022, the patient started taking orenitram (treprostinil diolamine) Tablet at a dose of 10 mg TID (three times daily) oral (strength, lot/batch number and expiration date: not provided) for Secondary pulmonary arterial hypertension.  On an unknown date, the patient received a dose of suspect pfizer biontech covid-19 vaccine not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation.  On 18-Oct-2023 the patient developed nausea, chills, feeling hot, feeling like she has a hangover (hangover)  11 months 15 days following the administration of Influenza vaccine, Pfizer biontech Covid-19 vaccine and treprostinil diolamine.  Action taken- Unknown for treprostinil diolamine and not applicable for other suspects.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse says that they received an email saying that the vaccines that they received were not within the allowable shipping window. Caller says that 6 of the vaccines have been administered to patients with no reported adverse event; stating shipment received were not with in the allowable shipping window vaccines were received cold and placed with no reported adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 6 patient(s) and it was reported that nurse says that they received an email saying that the vaccines that they received were not within the allowable shipping window. caller says that 6 of the vaccines have been administered to patients and shipment received were not with in the allowable shipping window vaccines were received cold and placed with no reported adverse event after receiving influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Sep-2023, the patient(s) received a unknown dose of suspect influenza quadrival A-B vaccine (lot number: UT8134JA; expiry date: 30-Jun-2024) via unknown route in unknown administration site for prophylactic vaccination. The information on batch number was requested.  On an unknown date in Sep-2023, nurse reported that they received an email saying that the vaccines that they received were not within the allowable shipping window. caller says that 6 of the vaccines have been administered to patients with no reported adverse event (poor quality product administered) (latency: same day) and shipment received were not with in the allowable shipping window vaccines were received cold and placed with no reported adverse event (product storage error) (unknown latency).  It was reported that vaccine was administered on 26-Sep-2023 and 27-Sep-2023.  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 and Regulatory Authority 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.  Additional information was received on 31-Oct-2023 from other health professional. Case validity was upgraded to valid case (incorrectly assessed as non-valid). Lot number and expiry date of suspect product was added. A new event of product storage error was added. Clinical course updated and test amended accordingly.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HD QIV was administered to a 9 year old patient with no reported AE; Initial information received on 31-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 9-years-old male patient who was administered 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. Concomitant: no other vaccines  On 25-Oct-2023, the 9-years-old patient received 0.7 mL dose of suspect influenza quadrival A-B high dose HV vaccine (unknown strength, formulation) (Batch number: UT8072DA; expiry date: 30-Jun-2024) via intramuscular route in the right deltoid for Immunization with no reported adverse event (product administered to patient of inappropriate age) (same day latency).  Action taken : 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: 13.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: extra dose of IPOL was administered to a patient with no adverse event; Initial information was received on 01-Nov-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 13 years old male patient who experienced extra dose of IPV (VERO) [IPOL] was administered to a patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) hepatitis b vaccine, hepatitis a vaccine and varicella zoster vaccine live (oka/merck) (varivax [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for prophylactic vaccination (Immunisation).  On 14-Oct-2010, the patient received a dose 1 of suspect IPV (VERO) ) (lot, dose, formulation, strength, and expiry date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination (immunization).  On 17-OCT-2023, the patient received 0.5 ml of suspect IPV (VERO) suspension for injection, (lot:V1B891M and expiry 01-Jun-24) (strength: not reported) via intramuscular route in the left deltoid  prophylactic vaccination (Immunization).  On 17-OCT-2023, the patient developed a non-serious extra dose of ipol was administered to a patient with no adverse event (extra dose administered) (latency 3 day).  Action taken: not applicable. 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: 63.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered the vaccine she asked the patient if she was 65 older but later realized the patient was 63 with no reported adverse event; Initial information received on 01-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 63 years old female patient whose nurse administered the vaccine of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] she asked the patient if she was 65 older but later realized the patient was 63 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Nov-2023, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number: U8162BA, expiry date: 30-Jun-2024, strength as standard) via intramuscular route in the left deltoid as prophylactic vaccination (product administered to patient of inappropriate age) (Latency: same day)  It was reported "Caller stated that she has already contacted the patient and would like to know the next steps she needs to take. All reps were assisting other callers Case placed in proxy for a call back. Caller stated that if someone calls her back before 4 pm she can be reached at the office number, if someone calls her after 4 pm she can be reached on her cell phone. The Pharmacist reported that when asked the consumer reported that they were 65 years of age; that it was not until after the vaccination and the patients information was placed in the system it flagged as being too young for the FLUZONE Quadrivalent High-Dose; that the consumer was called to report the event and the consumer asked the pharmacy how old is she and they were told they were only 63-years old; that the consumer's doctor was contacted about the event as well; and that the consumer is on oxygen."  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: 63.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone High-Dose Quadrivalent given to a 63yr old female with no reported adverse event; Initial information received on 01-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 63 years old female patient who was administered 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 0.7 ml total of suspect Influenza Quadrival A-B High Dose Hv Vaccine (lot number: U8162BA, Expiry date: 30-Jun-2024) (with an unknown formulation, strength) via unknown route in unknown administration site for immunization.  On an unknown date, the patient was administered Influenza Quadrival A-B High Dose Hv Vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, Fluzone High-Dose Quadrivalent given to a 63yr old female what actions need to be taken. Primary physician has been contacted. This situation is reported as an off-label use as per local labelling due to patient age. No additional information available from this first contact.   Action taken was not applicable. 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: 8.0
Sex: U
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired (9/30/23) Tenivac vaccine was administered to an 8 year old child with no adverse event; Initial information received on 01-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves expired (9/30/23) tenivac vaccine that was administered to an 8 year old child with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2023, the patient received a  dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection lot U7189AA, expiry- 30-Sep-2023 via unknown route in unknown administration site for prophylactic vaccination (strength, dose: unknown) with no adverse event (expired product administered) (latency same day).  Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: only received the diluent and not the lyophilized powder portion with no reported adverse event; Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2023SA343804, 2023SA343809 and 2023SA345528.  This case involves 15 months old male patient who only received the diluent and not the lyophilized powder portion for 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) for Immunisation and Hepatitis A Vaccine (Hepatitis A) for Immunisation.  On 26-Oct-2023, the patient received a standard dose 4 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml total (lot UK007AB, expiry date- 31-DEC-2024) via intramuscular route in the right thigh for Immunization.  On 26-Oct-2023, the patient only received the diluent and not the lyophilized powder portion with no reported adverse event (single component of a two-component product administered) (latency- same day) following the administration of HIB (PRP/T) vaccine.  Reportedly, Pharmacist reported that four patients received a dose of ACTHIB. However, one patient only received the diluent and not the lyophilized powder portion. They noticed there was one extra powder vial left but they are unsure which patient only received the diluent. Should they revaccinate all or should they do serologic testing prior to re-administering? Treatment: The caller was not aware of any adverse reactions, treatment.  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: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: patients received a dose of acthib. however, one patient only received the diluent and not the lyophilized powder portion with no reported adverse event; Initial information received from country on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2023SA343771, 2023SA345528 and 2023SA343809 .  This case involves a 1 years old male patient who received a dose of HIB (PRP/T) VACCINE [ACT-HIB] however, one patient only received the diluent and not the lyophilized powder portion 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); HEPATITIS A VACCINE (HEPATITIS A); and INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination (Immunization).  On 30-Oct-2023, the patient received a 0.5 mL dose 4 of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) (Frequency = once), (Strength = standard) (lot UK007AB and expiry date: 31-Dec-2024) via intramuscular route in the right thigh for Immunization.  On 30-Oct-2023, the patient received a dose of acthib. however, one patient only received the diluent and not the lyophilized powder portion with no reported adverse event (single component of a two-component product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE.  It was reported that "Pharmacist reported that four patients received a dose of ACTHIB. However, one patient only received the diluent and not the lyophilized powder portion. They noticed there was one extra powder vial left but they are unsure which patient only received the diluent. Should they revaccinate all or should they do serologic testing prior to re-administering?".  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 and Module of the 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: 1.33
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: only received the diluent and not the lyophilized powder portion with no reported adverse event; Initial information received from country on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2023SA343804, 2023SA343771 and 2023SA345528.  This case involves 16 months old male patient who only received the diluent and not the lyophilized powder portion for 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) for Immunisation; Hepatitis A Vaccine for Immunisation; and influenza vaccine (Flu [influenza vaccine]) for Immunisation.  On 30-Oct-2023, the patient received a standard dose 4 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml total (lot UK007AB, expiry date- 31-DEC-2024) via intramuscular route in the left thigh for Immunization.  On 30-OCT-2023 the patient only received the diluent and not the lyophilized powder portion with no reported adverse event (single component of a two-component product administered) (latency- same day) following the administration of HIB (PRP/T) vaccine.  Reportedly, Pharmacist reported that four patients received a dose of ACTHIB. However, one patient only received the diluent and not the lyophilized powder portion. They noticed there was one extra powder vial left but they are unsure which patient only received the diluent. Should they revaccinate all or should they do serologic testing prior to re-administering? Treatment: The caller was not aware of any adverse reactions, treatment.  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 and Module of the 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: FLUC3
Symptoms: Axillary mass, Injection site hypoaesthesia
Clinical narrative: Numbness on the backside of her arm, almost reaching the elbow / numbness seems to "wrap a little bit in her tricep"; Lump under her armpit; This spontaneous case was received on 03-Nov-2023 from other non-healthcare professional (consumer) via Med Communications (reference number: SEQW23-04015) and concerned a female patient of unreported age.   The patient's medical history was not reported. The patient's concomitant medications included Adderall (amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate), Zyrtec (cetirizine hydrochloride), unspecified supplements which contained vitamin D, fish oil, vitamin B12, and magnesium, all used for unspecified indications.  On an unspecified date, reported as 'on Friday', the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose; 0.5 ml; route of administration and anatomical location: not reported) for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. The batch number was not reported.  On an unspecified date, reported as 'on Sunday', an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced numbness on the backside of the arm, almost reaching the elbow. As reported, the numbness seemed to wrap a little bit in the triceps, although when the patient administered the shot, she did not feel pain and her arm was never sore and did not hurt. Also, the patient noticed she had a lump under her armpit.   The outcome of the events was not reported.   The reporter did not provide a causality assessment.  Company comment: A female patient of unreported age was vaccinated with the suspect product Flucelvax Quadrivalent. An unspecified time after vaccination the patient experienced numbness on the backside of the arm, almost reaching the elbow. Also, the patient noticed she had a lump under her armpit. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Due to limited information provided and unclear temporal relationship causality for the events hypoaesthesia and axillary mass is unassessable.; Sender's Comments: A female patient of unreported age was vaccinated with the suspect product Flucelvax Quadrivalent. An unspecified time after vaccination the patient experienced numbness on the backside of the arm, almost reaching the elbow. Also, the patient noticed she had a lump under her armpit. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Due to limited information provided and unclear temporal relationship causality for the events hypoaesthesia and axillary mass is unassessable.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Injection site haemorrhage, Syncope
Clinical narrative: Patient started bleeding after vaccination.  immunizer cleaned arm with alcohol swabs and applied pressure with gauze.  Patient stated she felt dizzy/faint.  Placed her on floor.  Placed a cold pack on arm and back of neck.  Called code white pharmacy.  AP came and called for Ambulance.  Ambulance came and took vitals.  Blood pressure was low.  Patient transported to hospital.  Patient was conscious throughout event and responded as needed.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administered incorrect vaccine, patient's parent was informed and advised to wait in case of reaction. Patient did not have any reaction and left clinic.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: It was the new yearly Covid 23-24-m SVD Comirnaty 12+ shot Went into Atrial fibrillation was in two different  hospitals
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC20
Symptoms: Immunoglobulin therapy, Kawasaki's disease, Nasal congestion, Pyrexia, Rash
Clinical narrative: Kawasaki disease diagnosed after 6 month vaccines. Of note, this was his first PCV20 immunization. Documentation suggests immunization 8/22/23 and fever, rash, nasal congestion 8/27/23 but parents deny nasal congestion/ viral symptoms being present at that time. RPP was negative. Admitted 8/29 with fever and rash; discharged 9/2/23. IVIG given 2 mg/kg 9/1/23. Aspirin given and stopped after discharge. No cardiac sequelae; discharged from cardiology.  Also interesting, I do not see record for checking COVID-19 antibodies during hospitalization. There is significant overlap between MIS-C and Kawasaki disease. I wonder if MIS-C could have been possible after very mild COVID-19 infection sometime in the prior months.  I did report this to VAERS since this would not typically be a vaccine reaction we think of. Especially with new PCV20 vaccination, this was reported.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: Pt reported waking up the next morning with hives starting on her stomach, and then spreading to side, arms and then all over. Pt states no other issue, but that also  she has had all Pfizer COVID vaccines and never had a reaction.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Injection site discharge, Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Patient stated that approximately 3 days after receiving the vaccine she started experiencing pain and burning around the injection site. She also said that the area was red, warm to the touch, and she felt a hard nodule in the area. She also complained of pain on the left side of her neck. On 11/13/23 she said she experienced blistering around the injection site and the area drained clear fluid. At the time of this report, patient was still experiencing pain in arm and neck, redness, and still felt a hard nodule under her skin.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Injection site vesicles, Injection site warmth, Neck pain
Clinical narrative: Patient stated that approximately 3 days after receiving the vaccine she started experiencing pain and burning around the injection site. She also said that the area was red, warm to the touch, and she felt a hard nodule in the area. She also complained of pain on the left side of her neck. On 11/13/23 she said she experienced blistering around the injection site and the area drained clear fluid. At the time of this report, patient was still experiencing pain in arm and neck, redness, and still felt a hard nodule under her skin.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash above belly button, approx 2? round
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Pain
Clinical narrative: Pt has severe pain all throughout body and headache
Age: 40.0
Sex: F
Vaccine: FLUA4
Symptoms: Fatigue, Injection site pain, Lymphadenopathy, Product administered to patient of inappropriate age
Clinical narrative: Patient inadvertently received the Fluad vaccine for patients over 65 despite being <65 years of age. Patient reported feeling pain at injection site the morning after vaccination (11/11/2023). She also noted swelling in the lymph nodes on the left side of her neck on 11/12/2023 and some slight fatigue which she states is typical for her following vaccination. She states her symptoms were not severe enough for her to find it necessary to take anything to help with pain.
Age: 43.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: Patient inadvertently received the Fluad vaccine for patients over 65 despite being <65 years of age.  Patient reported feeling pain at injection site the evening he received the vaccination (11/10/23). He stated his arm was still slightly sore the next morning  (11/11/2023) but then resolved. He states his symptoms were not severe enough for him to find it necessary to take anything to help with the pain. He has completely recovered from the adverse event.
Age: 24.0
Sex: F
Vaccine: FLUA4
Symptoms: Fatigue, Injection site pain, Musculoskeletal stiffness, Myalgia, Product administered to patient of inappropriate age
Clinical narrative: Patient inadvertently received the Fluad vaccine for patients over 65 despite being <65 years of age.  Patient reported feeling pain at injection site the following morning (11/11/2023) as well as fatigue, and muscle aches/stiffness. She took ibuprofen that morning and took another dose of ibuprofen at noon which resolved her symptoms.
Age: 34.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: Patient inadvertently received the Fluad vaccine for patients over 65 despite being <65 years of age.  Patient reported feeling pain at injection site the following morning (11/11/2023) but it was not any more severe than when he gets other vaccinations. It was not necessary for him to take anything to help with pain.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Cough, Fatigue, Headache, Influenza like illness
Clinical narrative: Day of sore arm and then over the next 2 days large area under my armpit ( called pharmacy) and explained my lymph nodes. Days following seemed to have a low grade flu feeling but ok.  Noticed more tired than usual and then nasal congestion. A cough started a few days ago but last night got worse like in my chest. Today in bed as headache and sore throat.  Not sure if all from vaccine response but took several covid over the counter tests negative.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: Day of sore arm and then over the next 2 days large area under my armpit ( called pharmacy) and explained my lymph nodes. Days following seemed to have a low grade flu feeling but ok.  Noticed more tired than usual and then nasal congestion. A cough started a few days ago but last night got worse like in my chest. Today in bed as headache and sore throat.  Not sure if all from vaccine response but took several covid over the counter tests negative.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB, IPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Extraneous IPV vaccine and out of range recommended age range with Pentacel (DtaP+Hib+IPV). Mother notified, no adverse effect/reaction reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Sight of injection became red, swollen and itchy within 18 hours after injection.  Patient developed a fever of 100.5, aches and pains, and joint pain.  She felt a hard lump that would not go away at site of injection.  Recommended at day three to take a Benadryl 25 mg, which relieved itching and swelling started to resolve.  At day 8, she is still having joint pain, especially in her knee and feels as if she can't put weight on that leg.  She was referred to her provider to follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Sight of injection became red, swollen and itchy within 18 hours after injection.  Patient developed a fever of 100.5, aches and pains, and joint pain.  She felt a hard lump that would not go away at site of injection.  Recommended at day three to take a Benadryl 25 mg, which relieved itching and swelling started to resolve.  At day 8, she is still having joint pain, especially in her knee and feels as if she can't put weight on that leg.  She was referred to her provider to follow up.
Age: 45.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Induration, Peripheral swelling, Pruritus, Rash, Skin warm
Clinical narrative: Covid arm.    Arm has rash, swelling and taunt hard large lump , skin is hot to touch and itchy..   begining days after injection
Age: 75.0
Sex: M
Vaccine: FLUA4, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient was given 2 doses of the fluad along with the Abrysvo.  No treatment was required and the patient did not experience any discomfort or adverse signs/symptoms.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Burning sensation, Pruritus, Rash, Stevens-Johnson syndrome, Stomatitis
Clinical narrative: PATIENT DEVELOPED STEVEN JOHNSON SYNDROME THE DAY AFTER RECEIVING VACCINE. PATIENT DEVELOPED RASH AND ITCHING  AND BURNING SENSATION ON NECK  AND WITH IN FEW DAYS BREAKOUT ON LEGS AND 3 SORES IN MOUTH .  EVEN AFTER 3 WEEKS PATIENT STILL HAS RASH ON LEGS
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Nausea
Clinical narrative: felt faint and nauseous within minutes of administration
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema multiforme, Rash, Rash pruritic
Clinical narrative: Rash (erythema multiforme) started on chest and spread to entire body. Rash got progressively worse over 4 days then started to taper down. Rash is extremely itchy and Benadryl and hydrocortisone cream were used.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hyperaesthesia, Pruritus, Urticaria
Clinical narrative: Within 2 weeks of receiving the vaccine, I started itching in various areas of my body, which then would produce welts. My Chronic  itching  and skin sensitivity has continued daily for 1 year now.  I take Allegra to reduce they symptoms.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: FEVER, SWELLING OF INJECTION SITE, INJECTION SITE PAIN, BODY ACHES, KNOT AT INJECTION SITE
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia
Clinical narrative: Severe joint pain all over especially overnight the night of vaccine and becoming more mild after about 10 AM the next morning. Then mild joint aches on and off for 4 days.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Laboratory test, Mobility decreased, Musculoskeletal disorder, Polymyalgia rheumatica
Clinical narrative: I could not move my arms/shoulders, to the extent that I could get out of bed and then could not get up from a couch.  I was taken to the ER and stayed for 5 days.  Prednisone allowed me to regain function.  I stayed on the steroid for about 1.5 years and then tapered off.  I still have symptoms, but less in my shoulders and hips, but more pain in knees.  I have been seen at 3 locations.
Age: 78.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia
Clinical narrative: Patient complains of joint pain starting in injection arm then moving to opposite shoulder and down into her hands.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Brain scan abnormal, Chest discomfort, Craniotomy, Deafness
Clinical narrative: -Awoke at 3:15am the night after the vaccine with vomiting and the worse headache of my life.  Later that day, I describe the pain as if my brain felt like it was tearing. I was unable to move or hold a conversation for about 12 hours. The pain decrease that same evening and was much decreased by the next day. I did not seek official care or diagnostic testing after hearing headaches were a common symptom and not wanting to expose myself to hospitals or urgent cares during the pandemic for fear of exposure.  -after returning to work sometime in the next few day,(2-4days later) I started to notice loss of hearing completely in my right ear for as short as 30secs. to several minutes, then hearing would return completely. This was accompanied by a strange sensation, of floating or cognitive perception change, that I much later was able to identify as partial seizures which had not occurred before the severe headache I had the night after the vaccine. This feeling that was caused by the partial seizures were frequent for the next several weeks and then tapered off and eventually flared up again later. Brain scans much later identified a capillary brain hemorrhage (cavernoma) with blood at various stages of clotting around the bleed site, the oldest dating back to the timeframe of my vaccine and first symptoms.  A craniotomy was performed to remove the mass and blood clotting, at that time it was about a 4cm diameter. The procedure was successful in correcting the problem but did have the unforeseen side effect of causing a secondary stroke in another section of the brain from the surgery.   -Separately I developed exercise induced chest tightness and pain. About 1.5-3 weeks after the second vaccine dosage.  I would experience little to no chest symptoms with ADLs until going on my exercise bike, try to run or other brisk cardiovascular activity. This symptom slowly decreased and was not noticed after about 5-7 months.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Exercise tolerance decreased, Fear, Feeling abnormal, Headache
Clinical narrative: -Awoke at 3:15am the night after the vaccine with vomiting and the worse headache of my life.  Later that day, I describe the pain as if my brain felt like it was tearing. I was unable to move or hold a conversation for about 12 hours. The pain decrease that same evening and was much decreased by the next day. I did not seek official care or diagnostic testing after hearing headaches were a common symptom and not wanting to expose myself to hospitals or urgent cares during the pandemic for fear of exposure.  -after returning to work sometime in the next few day,(2-4days later) I started to notice loss of hearing completely in my right ear for as short as 30secs. to several minutes, then hearing would return completely. This was accompanied by a strange sensation, of floating or cognitive perception change, that I much later was able to identify as partial seizures which had not occurred before the severe headache I had the night after the vaccine. This feeling that was caused by the partial seizures were frequent for the next several weeks and then tapered off and eventually flared up again later. Brain scans much later identified a capillary brain hemorrhage (cavernoma) with blood at various stages of clotting around the bleed site, the oldest dating back to the timeframe of my vaccine and first symptoms.  A craniotomy was performed to remove the mass and blood clotting, at that time it was about a 4cm diameter. The procedure was successful in correcting the problem but did have the unforeseen side effect of causing a secondary stroke in another section of the brain from the surgery.   -Separately I developed exercise induced chest tightness and pain. About 1.5-3 weeks after the second vaccine dosage.  I would experience little to no chest symptoms with ADLs until going on my exercise bike, try to run or other brisk cardiovascular activity. This symptom slowly decreased and was not noticed after about 5-7 months.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Imperception, Intracranial mass, Mobility decreased, Pain
Clinical narrative: -Awoke at 3:15am the night after the vaccine with vomiting and the worse headache of my life.  Later that day, I describe the pain as if my brain felt like it was tearing. I was unable to move or hold a conversation for about 12 hours. The pain decrease that same evening and was much decreased by the next day. I did not seek official care or diagnostic testing after hearing headaches were a common symptom and not wanting to expose myself to hospitals or urgent cares during the pandemic for fear of exposure.  -after returning to work sometime in the next few day,(2-4days later) I started to notice loss of hearing completely in my right ear for as short as 30secs. to several minutes, then hearing would return completely. This was accompanied by a strange sensation, of floating or cognitive perception change, that I much later was able to identify as partial seizures which had not occurred before the severe headache I had the night after the vaccine. This feeling that was caused by the partial seizures were frequent for the next several weeks and then tapered off and eventually flared up again later. Brain scans much later identified a capillary brain hemorrhage (cavernoma) with blood at various stages of clotting around the bleed site, the oldest dating back to the timeframe of my vaccine and first symptoms.  A craniotomy was performed to remove the mass and blood clotting, at that time it was about a 4cm diameter. The procedure was successful in correcting the problem but did have the unforeseen side effect of causing a secondary stroke in another section of the brain from the surgery.   -Separately I developed exercise induced chest tightness and pain. About 1.5-3 weeks after the second vaccine dosage.  I would experience little to no chest symptoms with ADLs until going on my exercise bike, try to run or other brisk cardiovascular activity. This symptom slowly decreased and was not noticed after about 5-7 months.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Partial seizures, Petechiae, Post procedural stroke, Thrombosis, Vomiting
Clinical narrative: -Awoke at 3:15am the night after the vaccine with vomiting and the worse headache of my life.  Later that day, I describe the pain as if my brain felt like it was tearing. I was unable to move or hold a conversation for about 12 hours. The pain decrease that same evening and was much decreased by the next day. I did not seek official care or diagnostic testing after hearing headaches were a common symptom and not wanting to expose myself to hospitals or urgent cares during the pandemic for fear of exposure.  -after returning to work sometime in the next few day,(2-4days later) I started to notice loss of hearing completely in my right ear for as short as 30secs. to several minutes, then hearing would return completely. This was accompanied by a strange sensation, of floating or cognitive perception change, that I much later was able to identify as partial seizures which had not occurred before the severe headache I had the night after the vaccine. This feeling that was caused by the partial seizures were frequent for the next several weeks and then tapered off and eventually flared up again later. Brain scans much later identified a capillary brain hemorrhage (cavernoma) with blood at various stages of clotting around the bleed site, the oldest dating back to the timeframe of my vaccine and first symptoms.  A craniotomy was performed to remove the mass and blood clotting, at that time it was about a 4cm diameter. The procedure was successful in correcting the problem but did have the unforeseen side effect of causing a secondary stroke in another section of the brain from the surgery.   -Separately I developed exercise induced chest tightness and pain. About 1.5-3 weeks after the second vaccine dosage.  I would experience little to no chest symptoms with ADLs until going on my exercise bike, try to run or other brisk cardiovascular activity. This symptom slowly decreased and was not noticed after about 5-7 months.
Age: 70.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Blood test normal, Computerised tomogram normal, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Patient reported having night sweats since having the vaccinations.  This prompted him to visit the ER. He also reported having light flu and body aches the next day after the vaccines.  He also experienced mild headaches and queasy.
Age: 70.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Nausea, Pain, Thyroid function test normal
Clinical narrative: Patient reported having night sweats since having the vaccinations.  This prompted him to visit the ER. He also reported having light flu and body aches the next day after the vaccines.  He also experienced mild headaches and queasy.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Sleep disorder
Clinical narrative: Pt called on 11/14/2023 to report he feels he may be having an adverse reaction to the flu shot he received on 11/10/2023. He reports he was in his usual health Friday and Saturday until the evening, when he developed a "pounding" headache. He was able to fall asleep, but was awoken by the pain around 2am and had to take Ibuprofen 600mg to resolves the symptoms and to get back to sleep. Since then he reports he has had to take Ibuprofen consistently every 6 hours. He denies any other symptoms including fevers, chills, myalgias, nasal congestion, cough, etc. He also denies any other neurologic symptoms including change in vision, imbalance, weakness, nausea or vomiting. He denies a prior history of similar headaches or migraine headaches.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Rash, Rash erythematous, Rash papular
Clinical narrative: Felt quite fatigued and had a persistent noticeable headache for over 24 hours that did not go away with Alleve.  Then, I noticed a pink rash all over my abdomen after a shower that was about 54 hours later.  It may've been there the day before, but I felt so bad, I went to bed early and did not look at my abdomen during that first day.  I could've missed it the first day because it was not bright red.  The rash was slightly raised, mildly itchy.  The rash was gone about 10 hours after I noticed it.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Rash pruritic
Clinical narrative: Felt quite fatigued and had a persistent noticeable headache for over 24 hours that did not go away with Alleve.  Then, I noticed a pink rash all over my abdomen after a shower that was about 54 hours later.  It may've been there the day before, but I felt so bad, I went to bed early and did not look at my abdomen during that first day.  I could've missed it the first day because it was not bright red.  The rash was slightly raised, mildly itchy.  The rash was gone about 10 hours after I noticed it.