chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patient was administered with punctured ipol with no reported adverse event; Initial information from Regulatory Authority was received on 29-Jan-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 years old male patient who was administered with punctured IPV (VERO) [IPOL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); HPV VACCINE (HPV VACCINE): VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); IPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 20-Dec-2023, the patient received punctured 0.5 ml, 1X-total of suspect IPV (VERO), Suspension for injection (lot W1C751M and expiry 18-NOV-2025) (strength: unknown) (poor quality product administered, latency same day) via intramuscular route in the right deltoid for prophylactic vaccination (immunization).  Reportedly:- Punctured IPOL Reason: Unknown Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C Duration: As stated above Human error: Unknown Administered: Yes. Does extended stability data cover the excursion: No  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: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temp. excursion due to unknown error, Max/low temperature reached: 9.3 C for 13 mins with no reported adverse event; punctured ipol was administered to patient post excursion with no reported adverse event; Initial information received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an 8 years old male patient who IPV (vero) [IPOL] temp. excursion due to unknown error, max/low temperature reached: 9.3 c for 13 mins with no reported adverse event and punctured ipol was administered to patient post 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 influenza vaccine for Prophylactic vaccination.  On 21-Dec-2023, the patient received 0.5 ml dose of suspect IPV (vero) Suspension for injection (lot W1C751M and expiration date- 18-Nov-2025) via intramuscular route in the left deltoid (strength: not provided) for Immunisation (product storage error) and (poor quality product administered).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 7.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Max/low temperature reached 9.3 C for 13 mins 10 C for 10 C was administered to patient with no reported adverse event; Initial information was received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old female patient to whom max/low temperature reached 9.3 c for 13 mins 10 c for 10 c was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine (flu vaccine]), hepatitis A vaccine, diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) and varicella zoster vaccine (varicella vaccine) for prophylactic vaccination.  On 22-Dec-2023, the patient received a 0.5 ml, total (once) dose of suspect IPV (VERO) (Suspension for injection) (lot: W1C751M, expiry date: 18-Nov-2025, Strength: standard) via intramuscular route in the left deltoid for Immunisation and max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c was administered to patients with no reported adverse event (poor quality product administered) (Latency: same day).  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: 14.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patient was administered with punctured ipol with no reported adverse event; Initial information was received on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 years old male patient who was administered with punctured IPV (VERO) [IPOL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); HPV VACCINE (HPV VACCINE): VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 28-Dec-2023, the patient received punctured 0.5 ml, 1X-total of suspect IPV (VERO), Suspension for injection (lot W1C751M and expiry 18-NOV-2025) (strength: unknown) (poor quality product administered, latency same day) via intramuscular route in the right deltoid for prophylactic vaccination (immunization).  Reportedly:- Punctured IPOL Reason: Unknown Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C Duration: As stated above Human error: Unknown Administered: Yes. Does extended stability data cover the excursion: No  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.
Age: 1.33
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Max/low temperature reached: 9.3 C for 13 mins with no reported adverse event; administration of punctured IPOL with no reported adverse event; Initial information received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a health professional.  This case involves a 16 months old male patient who was administered with punctured Ipv (Vero) [Ipol] which was exposed to max/low temperature reached: 9.3 c for 13 mins, 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 Influenza Vaccine and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Dtap) for Immunisation.  On 02-Jan-2024, the patient received (0.5 ml, once) dose of suspect Ipv (Vero), Suspension for injection, which was exposed to max/lo temperature reached: 9.3 c for 13 mins, with no reported adverse event (product storage error) (latency: unknown) and (poor quality product administered) (latency: same day) (strength: unknown) (lot: W1C751M, Expiry date: 18-Nov-2025) via intramuscular route in the left vastus lateralis for immunization.  No lab data reported.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administration of punctured IPOL that is not suitable for use, Max/low temperature reached: 9.3 C for 13 mins10 C for 10 C with no reported adverse event; Initial information received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 4 years old female (34th patient) patient who had administration of punctured IPV (VERO) [IPOL] that is not suitable for use, max/low temperature reached: 9.3 c for 13 mins10 c for 10 c 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 MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 08-Jan-2024, the patient received a dose of punctured suspect IPV (VERO) Suspension for injection (lot W1C751M, Expiry: 18NOV2025 with unknown strength and dose) via intramuscular route in the left deltoid as immunization and that is not suitable for use as max/low temperature reached: 9.3 c for 13 mins10 c for 10 c with no reported adverse event (poor quality product administered) (Latency: same day).  It was reported "the punctured IPOL previously was administered to 50 patients. Nurse also asked for recommendations if the patients need revaccination. Product/s: Punctured IPOL Reason: Unknown, Human error? Unknown Administered? Yes, it was administered to 50 patients."   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: 14.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Administered of punctured IPOL that had reached Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C which was not suitable for use with no adverse event; Initial information received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 14 years old male patient (patient number 35) who was administered punctured IPV (VERO) [IPOL] that had reached max/low temperature reached: 9.3 Celsius for 13 minutes 10 Celsius for 10 Celsius which was not suitable for use with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination (Immunization).  On 09-Jan-2024, the patient received 0.5 mL dose of punctured IPV (VERO) [IPOL] that had reached max/low temperature reached: 9.3 Celsius for 13 minutes 10 Celsius for 10 Celsius which was not suitable for use with no adverse event (poor quality product administered) (Suspension for injection) (latency: same day) (Frequency: once) (Strength: standard) (lot W1C751M and expiry date: 18-Nov-2025) via intramuscular route in the left deltoid for Immunization.  It was reported that "Nurse called back and added that the punctured IPOL she reported previously was administered to 50 patients. Nurse also asked for recommendations if the patients need revaccination. Human error? Unknown Administered? Yes, it was administered."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 9.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: punctured IPOL given to patient with no reported adverse event; Initial information received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 9 years old female patient (37th number) who had punctured IPV (VERO) [IPOL] given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 10-Jan-2024, the patient received a dose of  punctured suspect IPV (VERO) Suspension for injection (lot W1C751M, expiry date: 18-NOV-2025 with unknown strength) via intramuscular route in left deltoid as immunization with no reported adverse event (poor quality product administered) (latency; same day).  It was reported "the punctured IPOL previously was administered to 50 patients. Nurse also asked for recommendations if the patients need revaccination. Product/s: Punctured IPOL Reason: Unknown Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C Duration: As stated above Human error? Unknown Administered? Yes, it was administered to 50 patients."   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: 6.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Punctured IPOL underwent excursion of Max/low temperature reached: 9.3 C for 13 mins10 C for 10 C, was administered to 50 patients with no reported adverse event; Initial information was received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 6 years old female patient who had punctured IPV (VERO) [IPOL] underwent excursion of max/low temperature reached: 9.3 c for 13 mins10 c for 10 c, was administered to 50 patients 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 MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 16-Jan-2024, the patient received a dose of 0.5 ml of suspect IPV (VERO) (Suspension for injection) lot W1C751M , Expiry date: 18-Nov-2025, strength was unknown via intramuscular route in the left deltoid for Immunization and punctured ipol underwent excursion of max/low temperature reached: 9.3 c for 13 mins10 c for 10 c, was administered to 50 patients with no reported adverse event (poor quality product administered) (latency : same day).  Reportedly "As stated above Human error? Unknown Administered? Yes, it was administered to 50 patients. Does extended stability data cover the excursion? No Nurse verbally consented for a follow up in case Safety team wants additional information. See Transfer Screen for the details of patient 43. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data. This situation is pre-assessed as a medication error/an inappropriate use due to administration of punctured IPOL that is not suitable for use. "   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: M
Vaccine: IPV
Symptoms: Medication error, Poor quality product administered, Product storage error
Clinical narrative: Max/low temperature reached: 9.3 C for 13 mins ,10 C for 10 C with no reported adverse event; Max/low temperature reached: 9.3 C for 13 mins ,10 C for 10 C was administered to patient with no reported adverse event; Initial information received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient who administered punctured IPV (VERO) [IMOVAX POLIO] which was exposed to max/low temperature reached: 9.3 celsius for 13 minutes  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 23-Jan-2024, the patient administered 0.5 ml of punctured IPV (VERO) (lot W1C751M, expiry date: 18-Nov-2025, Strength = standard, Frequency = once) via intramuscular route in the right deltoid as immunization and it was exposed to max/low temperature reached: 9.3 celsius for 13 minutes (poor quality product administered) (product storage error) (Latency: same day).  The human error reported 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: 14.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Administered of punctured IPOL that had reached Max/low temperature reached: 9.3 C for 13 mins 10 C which was not suitable for use with no adverse event; Initial information received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 14 years old male patient who was administered punctured IPV (VERO) [IPOL] that had reached max/low temperature reached: 9.3 Celsius for 13 minutes 10 Celsius which was not suitable for use with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE); MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination (Immunization).  On 23-Jan-2024, the patient received 0.5 mL dose of punctured IPV (VERO) [IPOL] that had reached max/low temperature reached: 9.3 Celsius for 13 minutes 10 Celsius which was not suitable for use with no adverse event (poor quality product administered) (latency: same day) (Suspension for injection) (Frequency: once) (Strength: standard) (lot W1C751M and expiry date: 18-Nov-2025) via intramuscular route in the left deltoid for Immunization.  It was reported that "Nurse called back and added that the punctured IPOL she reported previously was administered to 50 patients. Nurse also asked for recommendations if the patients need revaccination. Human error? Unknown Administered? Yes, it was administered."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Loss of personal independence in daily activities, Nasopharyngitis, Tinnitus
Clinical narrative: Tinnitus in left ear  - White noise background with single high frequency tone;  sometimes not obvious while other times very annoying with difficulty of high concentration such as with studying;  exacerbate  with head colds
Age: 0.42
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 5 month old infant was inadvertently given incorrect vaccine.  Infant was scheduled to get Prevnar 20 vaccination.  However, medical assistant administered influenza vaccination *instead* of Prevnar 20.   In addition to this being incorrect vaccine, it was noted that infant was younger than minimum age for influenza vaccine.  After error realized, patient examined in office and noted to be well, including injection site.  Thus far, infant doing well without obvious adverse reactions or symptoms.
Age: 73.0
Sex: M
Vaccine: COVID19-2, RSV
Symptoms: Deep vein thrombosis, Pneumonia, Ultrasound Doppler abnormal
Clinical narrative: LOWER EXTREMITY VENOUS: EVIDENCE OF EXTENSIVE DVT IN THE PVT, PERONEAL VEINS AND GASTROCNEMIUS VEINS EXTENDING INTO THE POPLITEAL AND FEMORAL VEIN UP TO THE PROXIMAL THIGH. THESE VEINS ARE INCOMPRESSIBLE WITH NO FLOW  SEEN.  THIS WAS SUBJECT TO HOSPITALISATION TO TREAT THE BLOOD CLOT AND ELIQUIS TREATMENT 20 MG OVER A PERIOD OF 9 DAYS, THEN 10 MG STARTING JANUARY 12, 2024. I WAS  ALSO UNDER IV ANTIBIOTICS TO TREAT PNEUMONIA DURING THE  HOSPITALISATION  AND WITH A TREATMENT OVER 7 DAYS WITH AMOX PILLS.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Carditis, Heart rate increased, Oxygen saturation decreased
Clinical narrative: Cardiac inflammation, rapid HR, low blood oxygen.  Checked with pulse oximeter or wouldn't have known about the low blood oxygen:  HR 115, oxygen 91-92.  I had walked down and back up a hill about 30 mins. before, so oxygen should have been good.  Began about 1 p.m., continued for several hours.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site discomfort, Myalgia
Clinical narrative: High fever, shaking chills, muscle and joint aches, injection site discomfort, headache
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: High fever, shaking chills, muscle and joint aches, injection site discomfort, headache
Age: 6.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Abdominal pain upper, Arthralgia, Blood pressure decreased, Dizziness, Erythema
Clinical narrative: Patient noted passing out after vaccine administration. Pt vitals WNL prior to procedure. Pt fell over rolled off exam table and landed on her left side. Pt noted convulsing mildly on floor for about 5 seconds and became conscious after waving ammonia inhalant to nasal area. Pt placed in chair and noted pale and c/o dizziness.  Sips of water offered. Per Parents, Pt did not have breakfast or fluids and was agitated and nervous about receiving vaccines this morning. Pt AO X 3. BP taken again and noted low at 73/45 P58. This Nurse continued to monitor Pt. Pt c/o stomach ache and nausea. Pt did vomit some saliva and mucus. Pt noted with a pin/reddish area on left forehead but Pt did not c/o any pain. BP taken once again at 90/57 P66 returning to baseline. Parents stated Pt has never reacted in this way before after receiving vaccines. Pt seen before in October 2023 and received 3 vaccines without incident. This Nurse continued to monitor Pt for another 10 minutes. Pt noted able to ambulate without assistance and no longer c/o of nausea or dizziness but only some soreness on right knee. Will contact Parents to check on Pt.
Age: 6.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Loss of consciousness, Nausea, Pallor, Seizure, Vomiting
Clinical narrative: Patient noted passing out after vaccine administration. Pt vitals WNL prior to procedure. Pt fell over rolled off exam table and landed on her left side. Pt noted convulsing mildly on floor for about 5 seconds and became conscious after waving ammonia inhalant to nasal area. Pt placed in chair and noted pale and c/o dizziness.  Sips of water offered. Per Parents, Pt did not have breakfast or fluids and was agitated and nervous about receiving vaccines this morning. Pt AO X 3. BP taken again and noted low at 73/45 P58. This Nurse continued to monitor Pt. Pt c/o stomach ache and nausea. Pt did vomit some saliva and mucus. Pt noted with a pin/reddish area on left forehead but Pt did not c/o any pain. BP taken once again at 90/57 P66 returning to baseline. Parents stated Pt has never reacted in this way before after receiving vaccines. Pt seen before in October 2023 and received 3 vaccines without incident. This Nurse continued to monitor Pt for another 10 minutes. Pt noted able to ambulate without assistance and no longer c/o of nausea or dizziness but only some soreness on right knee. Will contact Parents to check on Pt.
Age: 61.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: PATIENT COMPLAINED ON 02/02/24 ABOUT RIGHT ARM PAIN AND INABILITY TO USE FULL MOTION OF ARM (LIFTING ITEMS OR RAISING ARM ABOVE HEAD).  PAIN STARTED AFTER ADMINISTRATION AND CONTINUED THROUGH TIME OF  PHARMACY NOTIFICATION, 02/03/2024
Age: 61.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Mobility decreased, Ultrasound scan
Clinical narrative: PATIENT COMPLAINED ON 02/02/24 ABOUT RIGHT ARM PAIN AND INABILITY TO USE FULL MOTION OF ARM (LIFTING ITEMS OR RAISING ARM ABOVE HEAD).  PAIN STARTED AFTER ADMINISTRATION AND CONTINUED THROUGH TIME OF  PHARMACY NOTIFICATION, 02/03/2024
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient had redness and a bunch and pain at vaccination site, was given 2 courses of Prednisone
Age: 72.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal stiffness, Myalgia
Clinical narrative: pain and stiffness in hips and shoulders, muscle pain throughout body
Age: 72.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Arthralgia, Myalgia
Clinical narrative: pain and stiffness in hips and shoulders, muscle pain throughout body
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough for more than a month
Age: 60.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Wrong product administered
Clinical narrative: the patient requested a vaccine for Tdap (Boostrix); I processed the paperwork and insurance for Tdap, but grabbed the wrong vaccine out of the refrigerator and it was Hep A/HepB (Twinrix);  These vaccines are made by the same manufacturers and have similar boxes.  I gave the vaccine for HepA/HepB before I realized my error.  I discovered my error and contacted the patient.  She came back to the pharmacy the same day and I administered the Tdap.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The patient called and described redness and swelling at the injection site.  She states she its warm and itchy.  She also states it looks like covid arm.  As of today, it is starting to get better
Age: 66.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Wrong product administered
Clinical narrative: The patient requested a vaccine for Tdap (Boostrix); I processed the paperwork and insurance for Tdap, but grabbed the wrong vaccine out of the refrigerator and it was  HepA/HepB (Twinrix); These vaccines are made by the same manufacturer and have similar boxes.  I gave the HepA/HepB vaccine to the patient before I realized my error.  I discovered my error and contacted the patient.   He returned to the pharmacy on the same day and I administered the Tdap that he had originally requested.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis
Age: 68.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Aphasia, Brain fog, Fatigue, Headache, Hypersomnia
Clinical narrative: This reporting process is somewhat vague. To be clear I may be sick for some other reason. However I typically work remotely and I?m not in close contact with many people.  About 3 weeks after vaccination was overcome by fatigue and slept almost 24/7 for three days, had severe brain fog, struggled to recall words on occasions, had unsettling dreams, mild headache that was treatable with Advil
Age: 68.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Nightmare
Clinical narrative: This reporting process is somewhat vague. To be clear I may be sick for some other reason. However I typically work remotely and I?m not in close contact with many people.  About 3 weeks after vaccination was overcome by fatigue and slept almost 24/7 for three days, had severe brain fog, struggled to recall words on occasions, had unsettling dreams, mild headache that was treatable with Advil
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: new onset atrial fibrillation diagnosed at cardiologist office - new onset atrial fibrillation after rsv vaccination is supposed to be monitored by the manuacturer following fda approval
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complains of blurry vision in left eye starting about 30 minutes after vaccination, as well as some left eye pain. Patient also complains of normal side effects: redness, swelling and pain at injection site, malaise,  fatigue.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Vision blurred
Clinical narrative: Patient complains of blurry vision in left eye starting about 30 minutes after vaccination, as well as some left eye pain. Patient also complains of normal side effects: redness, swelling and pain at injection site, malaise,  fatigue.
Age: 75.0
Sex: M
Vaccine: FLU4, PNC20
Symptoms: Arthralgia, Pruritus
Clinical narrative: he says he kinda itched all over a day or so after vaccine and then has extreme joint pain since the shot, all over his body
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Joint swelling, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Pain in both calves. Major inching for a few minutes, bad rash on both calves, minor rash on front of legs from knees down. K ees, calves and ankles swelled. Both legs felt bruised front and back from knees on down. Rash clear in a week. Swelling and both legs tender almost 2 weeks.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tenderness
Clinical narrative: Pain in both calves. Major inching for a few minutes, bad rash on both calves, minor rash on front of legs from knees down. K ees, calves and ankles swelled. Both legs felt bruised front and back from knees on down. Rash clear in a week. Swelling and both legs tender almost 2 weeks.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Mental status changes, Nausea
Clinical narrative: As per Care coordinator called on 2 /2/24, Altered mental status, dizziness, and nausea.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Hallucination, Memory impairment, Nervous system disorder, Speech disorder
Clinical narrative: Patient's wife called to report patient is hospitalized with CNS type SEs. Patient has trouble with memory, borderline nonverbal, mentioned hallucinations.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Echocardiogram, Electrocardiogram, Pericarditis
Clinical narrative: pericarditis
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient was 7 y/o but was accidently given the vaccine for 12 y/o and older.  There were no adverse events from this that we are aware of other than she got the wrong dose.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain
Clinical narrative: pt having nerve pain when moving arm
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Hypoaesthesia, Limb discomfort, Loss of personal independence in daily activities, Multiple sclerosis
Clinical narrative: Numbing and tingling in my lower extremities .  If I do to much as far as regular house cleaning legs and back become heavier. Cannot do extreme or long period of  being on my feet for long period of times. After shot was diagnosed with Multiple Sclerosis and taking Copaxone since the shot.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Numbing and tingling in my lower extremities .  If I do to much as far as regular house cleaning legs and back become heavier. Cannot do extreme or long period of  being on my feet for long period of times. After shot was diagnosed with Multiple Sclerosis and taking Copaxone since the shot.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Respiratory rate increased, Vaccine positive rechallenge
Clinical narrative: Rapid heart rate ranging from 100-105bpm, fast breathing. Lasted all night and continuing though decreased to ~80bmp range the following day
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Induration, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Swelling redness and swelling for more than a week increasing more each day, arm hard to touch and extremely warm, very itchy, painful, swollen lymph node, pain when lifting arm, in later days a new red spot appeared near the original as it went away the new one grew yet I had only gotten 1 shot, I also noticed the border of the redness go alone one of my veins as well
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Skin warm, Swelling
Clinical narrative: Swelling redness and swelling for more than a week increasing more each day, arm hard to touch and extremely warm, very itchy, painful, swollen lymph node, pain when lifting arm, in later days a new red spot appeared near the original as it went away the new one grew yet I had only gotten 1 shot, I also noticed the border of the redness go alone one of my veins as well
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Balance disorder, Corneal disorder, Eye pain, Gait disturbance, Infection
Clinical narrative: Pt complained of pain in her left eye starting 1/15/24. Went to the MD on 1/18/24. He prescribed Moxifloxacin Opthalmic Soln 0.5% 4 times a day 1 drop in left eye QID & valacyclovir HCl 1gm TID for 10 days saw him again on 2/2 & was informed to continue taking the moxifloxacin indefinitely & will be visiting again on 2/10. Now has floaters in left eye starting 1/29 & still has floaters & still has lingering pain in her eye. Was informed not to take Lotamax while taking valacyclovir. Put a "bandage" over left eye while not on the Lotamax
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster, Pain in extremity, Walking aid user
Clinical narrative: Pt complained of pain in her left eye starting 1/15/24. Went to the MD on 1/18/24. He prescribed Moxifloxacin Opthalmic Soln 0.5% 4 times a day 1 drop in left eye QID & valacyclovir HCl 1gm TID for 10 days saw him again on 2/2 & was informed to continue taking the moxifloxacin indefinitely & will be visiting again on 2/10. Now has floaters in left eye starting 1/29 & still has floaters & still has lingering pain in her eye. Was informed not to take Lotamax while taking valacyclovir. Put a "bandage" over left eye while not on the Lotamax
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Eye pain, Laboratory test, Vitreous floaters
Clinical narrative: Pt complained of pain in her left eye starting 1/15/24. Went to the MD on 1/18/24. He prescribed Moxifloxacin Opthalmic Soln 0.5% 4 times a day 1 drop in left eye QID & valacyclovir HCl 1gm TID for 10 days saw him again on 2/2 & was informed to continue taking the moxifloxacin indefinitely & will be visiting again on 2/10. Now has floaters in left eye starting 1/29 & still has floaters & still has lingering pain in her eye. Was informed not to take Lotamax while taking valacyclovir. Put a "bandage" over left eye while not on the Lotamax
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Corneal erosion, Eye pain, Gait disturbance, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Pt complained of pain in her left eye starting 1/15/24. Went to the MD on 1/18/24. He prescribed Moxifloxacin Opthalmic Soln 0.5% 4 times a day 1 drop in left eye QID & valacyclovir HCl 1gm TID for 10 days saw him again on 2/2 & was informed to continue taking the moxifloxacin indefinitely & will be visiting again on 2/10. Now has floaters in left eye starting 1/29 & still has floaters & still has lingering pain in her eye. Was informed not to take Lotamax while taking valacyclovir. Put a "bandage" over left eye while not on the Lotamax
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Walking aid user
Clinical narrative: Pt complained of pain in her left eye starting 1/15/24. Went to the MD on 1/18/24. He prescribed Moxifloxacin Opthalmic Soln 0.5% 4 times a day 1 drop in left eye QID & valacyclovir HCl 1gm TID for 10 days saw him again on 2/2 & was informed to continue taking the moxifloxacin indefinitely & will be visiting again on 2/10. Now has floaters in left eye starting 1/29 & still has floaters & still has lingering pain in her eye. Was informed not to take Lotamax while taking valacyclovir. Put a "bandage" over left eye while not on the Lotamax
Age: 27.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Placental calcification, Precipitate labour, Preterm premature rupture of membranes
Clinical narrative: PPROM, Precipitous labor, and aged placenta
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, COVID-19, Cardiac hypertrophy, Cardiac stress test abnormal, Cardiovascular symptom
Clinical narrative: 104+ temperaturs, severe body aches, heart palpation, dizziness, nausea/vomiting X 75 hrs after 2nd vaccine. I called the CDC hotline included with my vaccine info and they said what i was experiencing was"  a good immune response and I would probably never get covid" I got covid 7 wks later after being exposed to it daily as a nurse with no problems. How could the CDC give me that blatant lie info when it was experimental and they really didn't know what could happen?  I should hane been told to go to the hospital, as in retrospect I was having heart symptoms, that I also relayed to the CDC hotline however they downplayed my symptoms and told me not to worry about it unless it lasts more than three days.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Echocardiogram abnormal, Nausea, Occupational exposure to SARS-CoV-2, Pain
Clinical narrative: 104+ temperaturs, severe body aches, heart palpation, dizziness, nausea/vomiting X 75 hrs after 2nd vaccine. I called the CDC hotline included with my vaccine info and they said what i was experiencing was"  a good immune response and I would probably never get covid" I got covid 7 wks later after being exposed to it daily as a nurse with no problems. How could the CDC give me that blatant lie info when it was experimental and they really didn't know what could happen?  I should hane been told to go to the hospital, as in retrospect I was having heart symptoms, that I also relayed to the CDC hotline however they downplayed my symptoms and told me not to worry about it unless it lasts more than three days.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Vomiting
Clinical narrative: 104+ temperaturs, severe body aches, heart palpation, dizziness, nausea/vomiting X 75 hrs after 2nd vaccine. I called the CDC hotline included with my vaccine info and they said what i was experiencing was"  a good immune response and I would probably never get covid" I got covid 7 wks later after being exposed to it daily as a nurse with no problems. How could the CDC give me that blatant lie info when it was experimental and they really didn't know what could happen?  I should hane been told to go to the hospital, as in retrospect I was having heart symptoms, that I also relayed to the CDC hotline however they downplayed my symptoms and told me not to worry about it unless it lasts more than three days.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Pain, Pneumonia, Pyrexia
Clinical narrative: Fever 102.2, Chills, Body Aches, Fatigue. Two days later pneumonia
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: REDNESS AND WARMTH AT INJECTION SITE BEGINNING THE DAY AFTER VACCINATION. RED AREA NOT RAISED. MILD ITCHING THAT IS RELEIVED BY OTC HYDROCORTISONE CREAM. RED AREA APPROXIMATELY 3 INCHES IN DIAMETER.
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Chest pain, Heart rate increased
Clinical narrative: My husband told me that the night of the injection, he experienced rapid heart beat in the night, followed by chest pain. It resolved by the next day. He didn't report these side effects to a medical professional nor pharmacy.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Burning sensation, Pruritus, Rash, Urticaria
Clinical narrative: Hives, painful rash, itchy hands and feet, burning hands and feet.
Age: 13.0
Sex: F
Vaccine: IPV
Symptoms: Chest pain, Headache, Vision blurred, Visual field defect, Visual impairment
Clinical narrative: My daughter had a severe headache that started within an hour and she took Tylenol and went to bed. She woke up in the early morning because the headache was back. She took Tylenol again and went to school. Around 9:15 am in her 1st period class she started to have extremely blurred vision and could only see black triangles when she tried to look toward and to ths side she saw only black. The vision incident lasted 20-25 minutes. The severe headaches last all day on 2/2/24 and 2/3/24. She also experienced chest pain on the left side of her body. We called clinic  and spoke to a nurse on other dates and explained her symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, headache, nausea, sore arm
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal disorder
Clinical narrative: Excessive swelling, redness, warmth, and bruise at the injection site. Pain and limited use of the arm for 3 days. Mild intermittent pain on range of motion for 3 weeks following injection.Never experienced any side effects to any injections or medication in the past. Reported it to a nurse practitioner who recommended ibuprofen and zyrtec for pain and reduction of local reaction to injection.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Pain in extremity
Clinical narrative: Excessive swelling, redness, warmth, and bruise at the injection site. Pain and limited use of the arm for 3 days. Mild intermittent pain on range of motion for 3 weeks following injection.Never experienced any side effects to any injections or medication in the past. Reported it to a nurse practitioner who recommended ibuprofen and zyrtec for pain and reduction of local reaction to injection.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac ablation
Clinical narrative: Paroxysmal atrial fibrillation which turned into atrial fibrillation with rapid ventricular rate. Ablation procedure  was performed on 1-11-2024.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Extreme tinnitus
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Dyspnoea
Clinical narrative: Short of breath
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal disorder, Pain in extremity, Spinal X-ray abnormal, Spondylitis, X-ray limb normal
Clinical narrative: Sore right arm that never quit hurting. After 3 months I was no longer able to use my right arm and was in excruciating pain.  I have only experienced pain in right arm after the vaccination. Nothing on left side is in pain nor is my neck.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Fatigue, Irritability, Pyrexia, Rash
Clinical narrative: Fever >102 x 3 days followed by rash to face, neck, torso. Fatigue, decreased appetite, fussiness
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Vesicular rash along  dermatome on left costovertebral angle
Age: 59.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen injection site for more than 3 days
Age: 75.0
Sex: F
Vaccine: TYP
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Customer just reported the side effect yesterday, pain in her shoulder.she can not move her arm normally since that injection.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received a second dose of the vaccine when it is only recommended to receive 1 dose. Patient received first dose 11/07/23 and second dose on 01/30/24
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Expired product administered
Clinical narrative: I am writing this to express my deep concern and to seek clarification and resolution regarding an alarming situation that was brought to my attention. On January 4, 2024, I received a COVID-19 vaccination at Medical Center facility. Subsequently, on February 4, 2024, I was notified that the vaccine administered to me was beyond its use date.  The notification has caused me considerable anxiety about the potential health implications of receiving an expired vaccine. It is my understanding that vaccines administered beyond their use date may not only be less effective but could also pose risks to my health.