chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC15, PPV
Symptoms: Gene mutation identification test positive, Vaccination failure
Clinical narrative: poor response to pneumococcal vaccine; Literature report.  This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 13-year-old female patient who suffered a 14-day fever to rhinovirus with subsequent development of Hashimoto's thyroiditis. Concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) injection, administered for prophylaxis (dose, vaccination scheme, strength, lot #, expiration date, injection site and route of administration were not provided).  On an unknown date, considering patient's illness and her father's diagnosis (common variable immunodeficiency [CVID]), she underwent CVID workup which revealed low IgG, IgM, and IgA with poor response to pneumococcal (vaccination failure) and diphtheria vaccines. She has since tested positive for IKZF1 c.550C more than T variant, as her father. The outcome of the event was not reported.  Per internal guidelines, the event vaccination failure was assessed as related to pneumococcal vaccine (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  Additional information is not expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: tiredness; headache; muscle aches; mild chills; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tiredness), HEADACHE (headache), MYALGIA (muscle aches) and CHILLS (mild chills) in a 44-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 08-Nov-2024, the patient experienced FATIGUE (tiredness), HEADACHE (headache), MYALGIA (muscle aches) and CHILLS (mild chills). At the time of the report, FATIGUE (tiredness), HEADACHE (headache), MYALGIA (muscle aches) and CHILLS (mild chills) had not resolved.            No relevant concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: running noises; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of RHINORRHOEA (running noises) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (running noises). At the time of the report, RHINORRHOEA (running noises) outcome was unknown.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.  Concomitant product use was not provided by the reporter.  It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache
Clinical narrative: experienced headache for 6 weeks; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An 80-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "experienced headache for 6 weeks". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient truly never get headaches, she is 80 years old. When she had intermittent headache, she reported it to her HCP and ordered a CAT scan (CT scan) and it kind of went away. Caller added when she had headache a few weeks later after the administration she went back to the Pharmacy and asked the pharmacist if she needs to report it, the pharmacist said no.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Breast cyst, Mammogram
Clinical narrative: She has approximately 60 cysts in one of her breasts; has cyst in both breasts; This is a spontaneous report received from a Nurse.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST CYST (non-serious), outcome "unknown", described as "She has approximately 60 cysts in one of her breasts; has cyst in both breasts". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The Pfizer employee reported they have an individual, told that after receiving COVID vaccine (Clarified as Pfizer COVID Vaccine) she discovered that she had approximately 60 cysts in one of her breasts. It was encountered at a mammogram because she felt the lump. She felt multiple lumps so she went to have a mammogram, she also found that her doctor, who administrating the mammogram provided that form as well. She had the first two questions on the mammogram form, were asking about when and which side location they may have, the patient has received the COVID vaccine. The Pfizer employee did not have vaccination facility details such as name, mailing address and contact. The Pfizer employee believed she had two doses, but did not have any of that data. Causality: Pfizer employee stated, Yes, she did. Pfizer employee did not know any of that information other medical conditions, concomitant medications and lab test. Pfizer employee believed she still has the cyst but that was all Pfizer employee know, did not know her treatment plan, did not know anything. Pfizer employee believed she received the vaccine in each arm and that she has cyst in both breasts. Pfizer employee did not know that information when probed if the vaccines administered on same date with the Pfizer vaccine, time of onset of event and if there were any other vaccinations within four weeks prior to the first administration date of Pfizer COVID Vaccine and if there were any previous immunization with the Pfizer vaccine, Pfizer employee did not know her immunization history and other details regarding due date or any other dose.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Fall, Gait inability, Loss of personal independence in daily activities, Pain
Clinical narrative: could not see because her vision doubles, unable to function; Has fallen out of bed twice; could not walk/hasn't been able to walk properly; everything is aching so bad, I've been on excruciating pain; unable to function; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 83-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Nov2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIPLOPIA (medically significant), outcome "unknown", described as "could not see because her vision doubles, unable to function"; FALL (medically significant), outcome "unknown", described as "Has fallen out of bed twice"; GAIT INABILITY (medically significant), outcome "unknown", described as "could not walk/hasn't been able to walk properly"; PAIN (non-serious), outcome "unknown", described as "everything is aching so bad, I've been on excruciating pain"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "unable to function". Clinical course: After administration patient was unable to walk, could not see because her vision doubles, unable to function and has been on excruciating pain. She was kept her in bed for a day and a half, could not walk, could not see because her vision doubles, unable to function, her son called Emergency people and hospital and they said her vitals were all okay. Has fallen out of bed twice.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Diplopia, IVth nerve paralysis
Clinical narrative: 4th nerve palsy; inflammation of joints; double vision; This is a spontaneous report received from a Nurse.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IVTH NERVE PARALYSIS (medically significant), outcome "unknown", described as "4th nerve palsy"; ARTHRITIS (non-serious), outcome "unknown", described as "inflammation of joints"; DIPLOPIA (non-serious), outcome "unknown", described as "double vision".  Clinical course: It was unknown if the patient received any other vaccines on the same date as the Pfizer vaccine and unknown if the patient was taking any other medications within 2 weeks prior to the event onset and unknown if the patient received any other vaccines within 4 weeks prior to the first administration of the suspect vaccine  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event IVth nerve paralysis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202400260525 same reporter/patient, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Severe nausea; Tiredness; Chills; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Nov2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset Nov2024, outcome "unknown"; NAUSEA (non-serious) with onset Nov2024, outcome "unknown", described as "Severe nausea"; FATIGUE (non-serious) with onset Nov2024, outcome "unknown", described as "Tiredness".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Chills, Diarrhoea, Headache, Malaise
Clinical narrative: feeling ill; Headache; fever; chills; body aches/ body pain; nausea; diarrhea; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Nov2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 06Nov2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 09Nov2024, outcome "not recovered"; PAIN (non-serious) with onset 09Nov2024, outcome "not recovered", described as "body aches/ body pain"; CHILLS (non-serious) with onset 09Nov2024, outcome "not recovered"; DIARRHOEA (non-serious) with onset 09Nov2024, outcome "not recovered", described as "diarrhea"; MALAISE (non-serious) with onset 09Nov2024, outcome "not recovered", described as "feeling ill"; PYREXIA (non-serious) with onset 09Nov2024, outcome "not recovered", described as "fever"; NAUSEA (non-serious) with onset 09Nov2024, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient searched for information and found that most side effects show up 14-24 but she had severe illness approx. 3 days from the injections. She did not know if it was COVID, flu or the combination. She received both on 06Nov2024 and started feeling ill the afternoon of 09Nov2024. The patient was still ill, and it was 11Nov2024. She could barely get out of bed. She was not planning to receive both COVID and flu at the same time, but the pharmacy worker told her she could. She might be out of the norm, but she was miserable. She thought maybe she had a different virus, but the timing was odd, and these symptoms were like the ones she had when she had COVID.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: feeling ill; Headache; fever; chills; body aches/ body pain; nausea; diarrhea; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Nov2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 06Nov2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 09Nov2024, outcome "not recovered"; PAIN (non-serious) with onset 09Nov2024, outcome "not recovered", described as "body aches/ body pain"; CHILLS (non-serious) with onset 09Nov2024, outcome "not recovered"; DIARRHOEA (non-serious) with onset 09Nov2024, outcome "not recovered", described as "diarrhea"; MALAISE (non-serious) with onset 09Nov2024, outcome "not recovered", described as "feeling ill"; PYREXIA (non-serious) with onset 09Nov2024, outcome "not recovered", described as "fever"; NAUSEA (non-serious) with onset 09Nov2024, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient searched for information and found that most side effects show up 14-24 but she had severe illness approx. 3 days from the injections. She did not know if it was COVID, flu or the combination. She received both on 06Nov2024 and started feeling ill the afternoon of 09Nov2024. The patient was still ill, and it was 11Nov2024. She could barely get out of bed. She was not planning to receive both COVID and flu at the same time, but the pharmacy worker told her she could. She might be out of the norm, but she was miserable. She thought maybe she had a different virus, but the timing was odd, and these symptoms were like the ones she had when she had COVID.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Product administered to patient of inappropriate age
Clinical narrative: She was also heard coughing a fewtimes during the call.; patient was prescribed with ADACEL which  is contraindicated for anyone over 64, and she is 70; Initial information received on 18-Oct-2024 regarding an unsolicited valid  non-serious case received from a patient.  This case is linked to case-2024SA318752 .  This case involves a 70 years old female patient who was vaccinated with Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] ,adacel is contraindicated for anyone over 64, and she is 70  and she was also heard coughing a fewtimes during the call.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine ,which is contraindicated for anyone over 64, and she is 70 (product administered to patient of inappropriate age),she was also heard coughing a few times during the call (cough) (lot number, expiry ,dose, strength, route, administration site, latency : unknown)  for immunization.  Reportedly- She is frustrated why they have given her the drug if it is contraindicated for her age. She wants to know what is going to happen to her, if it is going to be effective or she is going to wind up with a permanent arm damaged getting a shot, that she is 6 years older than 64.   Information regarding batch number corresponding to the one at time of event occurrence was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA318752:02271317 (clone case)
Age: 11.0
Sex: U
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: came in for his t-dap booster (ADACEL), but was instead given d-tap (DAPTACEL) with no reported adverse event; Initial information received on 06-Nov-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old and unknown gender patient who came in for his t-dap booster (adacel) (diphtheria-2/tetanus/5 ac pertussis vaccine), but was instead given d-tap (daptacel) (diphtheria-15/tetanus/5 ac pertussis vaccine) 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 was instead given diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection via unknown route in unknown administration site for prophylactic vaccination (Immunisation) (strength, dose, batch and expiry unknown) who came for  t-dap booster (adacel) with no reported adverse event (wrong product administered) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 9.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: product administered after the excursion with no reported adverse event; Initial information received on 06-Nov-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 9 years old female patient to whom product (IPV (VERO) [IPOL]) administered after the excursion 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 (Tdap); Hepatitis b vaccine (Hepatitis b); Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr); and Hepatitis a vaccine (Hepatitis A) for Immunisation.  On 04-Nov-2024, the patient was administered IPV (VERO) 0.5 ml 1x (once) Suspension for injection Strength = standard lot W1C831M expiry -21-Nov-2025 via subcutaneous route in the right arm for Immunization after the excursion with no reported adverse event (poor quality product administered) (latency same day).  Nurse called to report a temperature excursion.Product/s: (Punctured) IPOL Reason: She said that the cause of the temperature excursion was unknown, but they had a new data logger, and she believes it was inaccurate. (01-Nov-2024) Max/low temperature reached: 11.6° C Duration: 30 minutes   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: patients received FLUZONE T after the excursion with no reported adverse event; Max/low temperature reached: 1.7CDuration: 170 minutes with no reported adverse event; Initial information received on 06-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases- US-SA-2024SA327658, US-SA-2024SA327025, US-SA-2024SA329148, US-SA-2024SA327426, US-SA-2024SA327349  This case involves a 5 years old female patient who received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] after the excursion and max/low temperature reached: 1.7cduration: 170 minutes with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-OCT-2024 max/low temperature reached: 1.7cduration: 170 minutes with no reported adverse event (product storage error).  On 28-Oct-2024, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE  0.5 ml 1x (once) Suspension for injection lot UA435AA expiry-30-Jun-2025 via intramuscular route in the left deltoid for influenza (Immunisation) (strength standard) after the excursion with no reported adverse event (poor quality product administered) (latency same day).  Cause: The exact reason is unknown to the reporter; states that it may have been because they were in and out of the refrigerator and left the door open for too long, human error   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA327349: US-SA-2024SA327426: US-SA-2024SA329148: US-SA-2024SA327025: US-SA-2024SA327658:
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: patients received FLUZONE T after the excursion with no reported adverse event; the refrigerator and left the door open for too long.Max/low temperature reached: 1.7CDuration: 170 minutes, with no reported adverse event; Initial information received on 06-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Punctured influenza TRIVAL A-B subvirion vaccine [Fluzone] exposed to temperature excursion due to the refrigerator and left the door open for too long. max/low temperature reached: 1.7c duration: 170 minutes, and a 15 years old female patient received after the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine VLP rL1 4v (yeast) (Gardasil) for Immunisation.  On 09-Oct-2024 Punctured influenza USP TRIVAL A-B subvirion vaccine [Fluzone] exposed to temperature excursion due to the refrigerator and left the door open for too long. max/low temperature reached: 1.7c duration: 170 minutes with no reported adverse event (product storage error).  On 25-Oct-2024, the patient received 0.5 ml of Punctured influenza USP TRIVAL A-B subvirion vaccine Suspension for injection (strength- standard, lot UA435AA and expiry date- 30-Jun-2025) once via intramuscular route in the left deltoid for Influenza after the excursion with no reported adverse event (poor quality product administered) (latency- same day). Human error was involved.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. ; Sender's Comments:  US-SA-2024SA327135:cluster case
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient called pharmacy on 11/15/24 to report pain in injection arm that began approximately 2 hours after Fluad injection on 10/15/24.   Patient described experiencing severe pain for 48 hours after the injection.  It is now 4 weeks post vaccination and patient has mild to moderate pain at this time of reporting.  She is treating the pain with OTC anti-inflammatory medication (Advil).  The patient did not report this adverse event to the pharmacy immediately after the injection.  The patient did not seek the care of a physician .   She was instructed at the time of this report to follow up with a physician for examination.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Dizziness, Pallor
Clinical narrative: Patient received vaccines here at 4:27PM. Reported to feel "dizzy" after HPV9 vaccine. He appeared pale. Instructed pt to lay down on bench. Gave popsicle and candy. no syncope episode. no vomiting. After approx 10 mins, pt reported "feeling better".  Pallor had resolved.  Advised to increase water intake (gave bottle water) and he was able to ambulate w/o difficulty.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: patient received 2 flu shots at 2 different locations on the same day
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: One of our Medical assistants gave a second dose of Fluzone to the patient.  I contacted the patient, and she stated that she did not have a reaction and feels fine.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient requested RSV vaccine due to national advertising indicating she should get one every season.  Vaccinator checked state immunization registry and billed to insurance before giving vaccine, both indicating patient was eligible.  However, patient told vaccinator after the fact that she received an RSV vaccine the prior year in another state.  At time of vaccination there were no adverse effects noted.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site nodule, Musculoskeletal stiffness, Neck pain, Rash macular
Clinical narrative: Patient reported red blotches on the abdomen. Left arm (site of injection) has a knot and redness, Stiff back and neck pain
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Mental impairment
Clinical narrative: Pt received Flublok on 11/7/24, on 11/13/24, pt felt dizzy, had trouble thinking, and facial numbness.  At this point pt took blood pressure at home, he had been having blood pressure issues recently and had made a change to his medication in the recent past(increasing from Amlodipine 2.5mg to Amlodipine 5mg).  The result was 186/113, so pt went to the ER.  The dr at the hospital reduced the Amlodipine back down to 2.5mg daily and added Lisinopril 10mg.  Pt was discharged and now feels much better.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Urticaria
Clinical narrative: PATIENT REPORTED SHE IS FEELING DIZZY 3 MINUTES AFTER VACCINATION, WHILE SHE WAS IN OBSERVATION, HIVES IN COLLAR AREA WERE NOTCED, EPIPEN WAS DELIVERED, PATIENT FELT BETTER IN FEW MINUTES, PATIENT DID NOT REQUEST AMBULANCE, AND SHE SAID HER SISTER WILL PICK HER UP, PATIENT SUMPTOMS ALLERGY SYMPTOMS STARTED TO FADE, IN 30 MINUTES AFTER EPIPEN SHOT PATIETN SEEMED TO BE FULLY RECOVERING, PATIENT WAS EDUCATED ABOUT POSSIBLE ALLERGY TO A COMPONENT OF VACCINE, POSSIBLY EGGS.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Fluad on 8/26/2024 and Fluad on 11/12/2024. Patient experienced no side effects per patient.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness to left arm around injection site. Has been taking benadryl, applying ice, hydrocortisone topical;, advil.
Age: 49.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Asthenia, Foaming at mouth, Nausea, Unresponsive to stimuli, Vomiting
Clinical narrative: 11/14/24: (11:40AM)  STARTING 1 HOUR AFTER ADMIN EXPERIENCED WEAKNESS, NAUSEA, VOMITTING, FOMING OF THE MOUTH, NON-RESPONSIVENESS. BUT REFUSED TO GOT ER.  11/15/24: SIMILAR TO 11/14 BUT MORE SEVERE. PATIENT WAS ADMITTED TO ER ON 11/15/24 AROUND 2PM.
Age: 90.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Balance disorder, Dizziness, Urinary tract infection
Clinical narrative: PT received Fluzone HD on 11/11/24, on 11/12/24 pt felt dizzy and unstable, resulting in a trip to the ER.  Pt was admitted and subsequently diagnosed with a urinary tract infection, which was described as the likely culprit for the pt's reaction on 11/12/24.  Pt was discharged on 11/14/24 with oral antibiotics for the UTI.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was a 24 year old female. NP ordered an adult Hep B vaccine but a pediatric Engerix-B  hep B 10mcg/0.5ml was given. No adverse reaction. Patient did return to clinic for an additional dose of Engerix-B hep B 10mcg/0.5ml dose to equal an adult dose. No reaction noted.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Nausea
Clinical narrative: nause and diarrhea
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Muscular weakness
Clinical narrative: Muscle weakness with fall.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient requested vaccine now that he was 65. He was vaccinated with Flucelvax in July 2024 but wanted to get the 65+ vaccine. No reported issues after the vaccine.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Donor reports swelling, redness and warmth at the injection site, donor was counseled on care to injection site, donor advised to seek medical attention if symptoms continue or worsen, donor expressed understanding.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient became light headed after receiving vaccine and he became unconscious in the chair. He woke up shortly, drank some water and was ok to leave.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-thrombin antibody, Antiphospholipid antibodies negative, C-telopeptide, Cardiac monitoring normal, Cardiolipin antibody negative
Clinical narrative: Got the mandatory vaccine 11/16/03 in the left arm.  On 1/4/24 I had severe chest pain, lasted about 10 min.  I have esophageal spasms so thought that was the problem, though worse.  Went to bed.  In the morning 01/05/24 woke with left arm pain.  Got up for work, getting ready and arm went limp, severe bandlike pain for about 10 min.  Severe pain improved, but was sore.  For a couple of days continued to have left arm discomfort, tingling, cold.  Have hx Ulnar nerve entrapment and this felt similar, but was upper arm.  I thought I probably had a pinced nerve in my neck so I ignored it until 1/8/24 my arm color changed and I had no radial pulse.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Coagulation factor V level normal, Computerised tomogram limb, Echocardiogram
Clinical narrative: Got the mandatory vaccine 11/16/03 in the left arm.  On 1/4/24 I had severe chest pain, lasted about 10 min.  I have esophageal spasms so thought that was the problem, though worse.  Went to bed.  In the morning 01/05/24 woke with left arm pain.  Got up for work, getting ready and arm went limp, severe bandlike pain for about 10 min.  Severe pain improved, but was sore.  For a couple of days continued to have left arm discomfort, tingling, cold.  Have hx Ulnar nerve entrapment and this felt similar, but was upper arm.  I thought I probably had a pinced nerve in my neck so I ignored it until 1/8/24 my arm color changed and I had no radial pulse.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram normal, Electrocardiogram normal, Flow cytometry, Full blood count normal, Gene mutation identification test negative
Clinical narrative: Got the mandatory vaccine 11/16/03 in the left arm.  On 1/4/24 I had severe chest pain, lasted about 10 min.  I have esophageal spasms so thought that was the problem, though worse.  Went to bed.  In the morning 01/05/24 woke with left arm pain.  Got up for work, getting ready and arm went limp, severe bandlike pain for about 10 min.  Severe pain improved, but was sore.  For a couple of days continued to have left arm discomfort, tingling, cold.  Have hx Ulnar nerve entrapment and this felt similar, but was upper arm.  I thought I probably had a pinced nerve in my neck so I ignored it until 1/8/24 my arm color changed and I had no radial pulse.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotonia, Limb discomfort, Metabolic function test normal, Pain in extremity, Paraesthesia
Clinical narrative: Got the mandatory vaccine 11/16/03 in the left arm.  On 1/4/24 I had severe chest pain, lasted about 10 min.  I have esophageal spasms so thought that was the problem, though worse.  Went to bed.  In the morning 01/05/24 woke with left arm pain.  Got up for work, getting ready and arm went limp, severe bandlike pain for about 10 min.  Severe pain improved, but was sore.  For a couple of days continued to have left arm discomfort, tingling, cold.  Have hx Ulnar nerve entrapment and this felt similar, but was upper arm.  I thought I probably had a pinced nerve in my neck so I ignored it until 1/8/24 my arm color changed and I had no radial pulse.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Peripheral embolism, Protein S normal, Pulse absent, Russell's viper venom time normal
Clinical narrative: Got the mandatory vaccine 11/16/03 in the left arm.  On 1/4/24 I had severe chest pain, lasted about 10 min.  I have esophageal spasms so thought that was the problem, though worse.  Went to bed.  In the morning 01/05/24 woke with left arm pain.  Got up for work, getting ready and arm went limp, severe bandlike pain for about 10 min.  Severe pain improved, but was sore.  For a couple of days continued to have left arm discomfort, tingling, cold.  Have hx Ulnar nerve entrapment and this felt similar, but was upper arm.  I thought I probably had a pinced nerve in my neck so I ignored it until 1/8/24 my arm color changed and I had no radial pulse.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Ultrasound Doppler normal
Clinical narrative: Got the mandatory vaccine 11/16/03 in the left arm.  On 1/4/24 I had severe chest pain, lasted about 10 min.  I have esophageal spasms so thought that was the problem, though worse.  Went to bed.  In the morning 01/05/24 woke with left arm pain.  Got up for work, getting ready and arm went limp, severe bandlike pain for about 10 min.  Severe pain improved, but was sore.  For a couple of days continued to have left arm discomfort, tingling, cold.  Have hx Ulnar nerve entrapment and this felt similar, but was upper arm.  I thought I probably had a pinced nerve in my neck so I ignored it until 1/8/24 my arm color changed and I had no radial pulse.
Age: 88.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient's daughter informed pharmacy team on 11/12/24 that later that evening on 10/7/24 on date of his vaccinations, his right arm became sore, swollen and painful at area of injection in addition when trying to move arm.  The swelling did subside as of right now, but the pain still persists along with difficulty raising his right arm which required assistance from others or from his other arm to raise it.  Patient's family states he has an upcoming appointment with his provider. Informed patient to reach out to provider for further guidance.  Have tried to use acetaminophen OTC to help alleviate with pain was what was informed to pharmacy team.
Age: 37.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Pallor, Presyncope
Clinical narrative: Patient received flu and COVID vaccines around 5:10pm, and then started feeling faint and pale around 5:13pm. Immediately elevated patient's legs, and bystander provided water. Patient was able to drink water and was able to carry on conversation. Asked patient to remain seated for 30 minutes with legs elevated. Offered to call paramedics, but patient declined. Patient's breathing appeared normal throughout the time and did not feel any worse. Asked patient to let the primary care provider know about the incident today and to wait 30 minutes after getting a vaccine going forward, and to let any vaccinator and phlebotomist know about the fainting after getting vaccination. Patient felt was feeling better by 5:45pm and left without any further incident. Initial symptoms appeared to be consistent with vasovagal reaction.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: Donor had successfully completed plasma donation and donated a total of 692 mL of plasma.  500 mL of procedural saline.  A snack was provided post donation and Donor said she was feeling fine.  Approximately five minutes later she said she felt like she was going to faint and throw up.  Emesis bag was provided along with ice packs to front and back.  Vital signs monitored closely and she slowly regained color in her face.  There was no fainting, loc, or vomiting.   Our Center Medical director will do an additional chart review prior to any further participation in donations or vaccination,
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Gait disturbance, Joint stiffness, Pain in extremity, Skin warm
Clinical narrative: ON 10/24/24 - PT FELT LIKE HER KNEES "CEASED UP" AS IN LOCKED AND COULDN'T WALK. PATIENT ALSO HAD TROUBLE SWALLOWING BUT SAID THAT WAS MOMENTARILY BUT CAME AND WENT A FEW TIMES TIL 10/25/24. ALSO HAD HOT PAIN IN HER FINGERS
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Condition aggravated, Toothache, X-ray dental
Clinical narrative: I started with a mild toothache that got worse over the course of a week.  I visited the dentist who could not see anything wrong so she referred me to an endodontist.   I am waiting for the appointment.
Age: 13.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Syncope
Clinical narrative: patient fainted 5-15 min after getting shot
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: local skin reaction at site vaccine was administered. stable minimally symptomatic but acutely worsening at presentation. monitoring for now
Age: 31.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain, Back pain, Exposure during pregnancy
Clinical narrative: 35 weeks pregnant with a due date of 12/16. The evening after receiving the vaccine I had both abdominal cramping and severe back pain (that felt like constant back labor) into the morning. I made an appointment with my doctor and am continuing to monitor the systems. I have taken Tylenol and had a bath to try to reduce the pain.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chest pain, Dyspnoea, Electrocardiogram normal, Pleurisy
Clinical narrative: Wife came in to inform me symptoms of pleurisy, stabbing chest pain, SOB.  Symptoms started on 11/11, pt went to ER on 11/12, EKG ruled out heart attack.  Blood work ruled out bacterial and viral infection.
Age: 1.08
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt was given Covid vaccine Lot # LN6739 exp 11/20/24 on 11/13/24 less than 8 wks after Dose #2 (in total) no adverse reaction noted.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling greater than 3 inches at sight
Age: 81.0
Sex: F
Vaccine: COVID19, FLU3, PNC20, RSV
Symptoms: Fatigue, Muscular weakness
Clinical narrative: Extreme lower extremety weakness fatigue
Age: 28.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Pregnant female at 34 weeks gestation received the incorrect RSV vaccine. Patient received Arexvy when she should have received Abrysvo. Arexvy is not intended nor is it approved for pregnant individuals. Infant born 11/XX with birth weight of 3885g. Infant will receive niresevimab per peds ID recommendations.
Age: 28.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: Pregnant female at 34 weeks gestation received the incorrect RSV vaccine. Patient received Arexvy when she should have received Abrysvo. Arexvy is not intended nor is it approved for pregnant individuals. Infant born 11/XX with birth weight of 3885g. Infant will receive niresevimab per peds ID recommendations.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOC20241108000012 (Moderna).  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Feb2021 as dose 1, single (Lot number: 011A21A), in 2021 as dose 2, single (Lot number: 007B21A) and in 2022 as dose 3 (booster), single) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The clinical course was reported as follows: It was reported that the patient had the Moderna series originally when COVID came out and then the patient had one Moderna booster. Then the patient had the booster with Pfizer and the patient knew with the Moderna did not get COVID. When the patient had the booster with Pfizer, got it like a couple of months later. The patient stated that it seems that Moderna vaccine was more effective because the patient was in the car with person who had COVID and the patient did not get it when the patient had the Moderna shot, and was in a restaurant, got it two months after getting the booster from Pfizer. The patient had the Pfizer shot two months before getting the COVID and then it was over a year that the patient had the Moderna shot before the patient got COVID. The patient had the series in 2022 and in 2021 the patient had the original series. In 2022 the patient had the first Moderna booster just was one shot and then got the one shot of Pfizer.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vomiting
Clinical narrative: vomiting, fatigue, headache, and chills
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Renal pain, Sleep disorder
Clinical narrative: Extreme pain in my right kidney.  It started first with an ache, then I got sharp pains sporadically.  I took 2 Extra Strength Tylenol so I could sleep.  I had difficulty laying down on my side or back.  I have never had this type of reaction to any other vaccine.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Incorrect dose administered, Nausea, Vomiting
Clinical narrative: Patient received an adult Volume of the vaccine -  50 mcg of Spikevax accidentally. Her symptoms included vomiting, nausea, and fatigue.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Patient given a second flu shot instead of her Tdap during pregnancy.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Product administered to patient of inappropriate age, Vomiting
Clinical narrative: Patient received an adult volume of the vaccine - Spikevax 50 mcg. Her symptoms included vomiting, nausea, and fatigue. The symptoms lasted about 48 hours.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Glossodynia, Oropharyngeal pain, Pharyngeal swelling, Swollen tongue, Throat irritation
Clinical narrative: Throat and tongue swelling, painful, burning.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Tongue discomfort
Clinical narrative: Throat and tongue swelling, painful, burning.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypophagia, Product administered to patient of inappropriate age
Clinical narrative: Patient received an adult dose of the vaccine on accident - Spikevax 50 mcg. Patient experienced fatigue (didn't want to play) and nausea (hardly ate anything) for about 48 hours.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Facial pain, Swelling of eyelid
Clinical narrative: L eyelid swelling, L cheek pain.  UNKNOWN what brand of influenza vax
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Blood gases normal, Blood magnesium normal, Blood potassium decreased, Blood pressure abnormal, C-reactive protein normal
Clinical narrative: Shortness of breath, dizziness, tachycardia upon standing with heart beat increase between 30-65 beats per minute, lightheadedness, fainting, nausea, blood pressure dysfunction
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Contrast echocardiogram, Dizziness, Drug screen negative, Dyspnoea, Echocardiogram normal
Clinical narrative: Shortness of breath, dizziness, tachycardia upon standing with heart beat increase between 30-65 beats per minute, lightheadedness, fainting, nausea, blood pressure dysfunction
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Electroencephalogram normal, Fibrin D dimer normal, Full blood count normal, Heart rate increased
Clinical narrative: Shortness of breath, dizziness, tachycardia upon standing with heart beat increase between 30-65 beats per minute, lightheadedness, fainting, nausea, blood pressure dysfunction
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Nausea, Red blood cell sedimentation rate normal, Syncope, Tachycardia
Clinical narrative: Shortness of breath, dizziness, tachycardia upon standing with heart beat increase between 30-65 beats per minute, lightheadedness, fainting, nausea, blood pressure dysfunction