chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: excursion vaccine was administered with no adverse event; vaccine Act-HIB for which cold chain break is reported with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] for which cold chain break and excursion is reported with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (expiry date and batch number unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) for which cold chain break and excursion is reported with no reported adverse event (product storage error) (poor quality product administered) (same day latency). Information on the batch number was requested.  It was reported that children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window.  It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event excursion vaccine was administered with no reported adverse and was Unknown for the event act-hib for which cold chain break is reported with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA124713:MASTER CASE
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Products were not good and needed to be returned with no reported adverse event; poor quality vaccine administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2023SA124713(CLUSTER) and 2023SA129811(CLUSTER).  This case involves Infant and unknown gender patient for whom who poor quality vaccine administered with no reported adverse event while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date the cold chain break is reported where products were not good and needed to be returned with no reported adverse event (product storage error) and patient received a dose of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection with unknown strength, dose, batch number, expiry date via unknown route in unknown administration site for Immunization with no reported adverse event (poor quality product administered) (latency: same day). Batch number was requested.  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.   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.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Poor quality vaccine administered with no reported adverse event; Products were not good and needed to be returned with no reported adverse event; Initial information was received on 19-Apr-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to case 2023SA129826.  This case involves Infant and unknown gender patient who involved in the products HIB (PRP/T) VACCINE [ACT-HIB] were not good and needed to be returned and poor quality vaccine administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml dose of suspect products HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot number: UJ756AAA, expiry date: 12-Aug-2023, strength, route administrative site: Unknown) for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious products were not good and needed to be returned with no reported (product storage error) and poor quality vaccine administered with no reported adverse event (poor quality product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE.  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for both the event products.  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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: excursion vaccine was administered with no reported adverse event; vaccine Act-HIB for which cold chain break is reported with no reported adverse event.; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] for which cold chain break and excursion is reported with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (expiry date and batch number unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) for which cold chain break and excursion is reported with no reported adverse event (product storage error) (poor quality product administered) (same day latency). Information on the batch number was requested.  It was reported that children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window.  It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event excursion vaccine was administered with no reported adverse and was Unknown for the event act-hib for which cold chain break is reported with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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-2023SA124713:master case
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: products were not good and needed to be returned with no reported adverse event; excursion vaccine was administered were within 2, 4, and 6 months of age with no adverse event; Initial information was received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who involved in the products haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] were not good and needed to be returned and excursion vaccine was administered were within 2, 4, and 6 months of age with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 ml of total (1X) suspect hib (prp/t) vaccine Powder and solvent for solution for injection (lot number: UJ756AAA , Expiry date: 12-Aug-2023) (strength: Unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) were not good and needed to be returned with no reported adverse event (product storage error) (unknown latency) and was administered were within 2, 4, and 6 months of age with no adverse event (poor quality product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event excursion vaccine was administered were within 2, 4, and 6 months of age with no adverse event and was Unknown for the event products were not good and needed to be returned with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, Poor quality product administered, Product storage error
Clinical narrative: excursion vaccine was administered with no reported adverse event; Act-HIB for which cold chain break is reported with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] for which cold chain break and and excursion is reported with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (expiry date and batch number unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) for which cold chain break and and excursion is reported with no reported adverse event (product storage error) (poor quality product administered) (same day latency). Information on the batch number was requested.  It was reported that children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window.  It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event excursion vaccine was administered with no reported adverse and was Unknown for the event act-hib for which cold chain break is reported with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: poor quality vaccine administered with no reported adverse event; cold chain break is reported and excursion vaccine was administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient and reporter reported cold chain break of haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] is reported and excursion vaccine was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection (lot number, strength, dosage, expiry date- not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on the batch number was requested  On an unknown date the caller reported cold chain break of haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] (product storage error) and excursion vaccine was administered to patient with no reported adverse event (poor quality product administered) (latency- same day).  Action taken was 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.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: arrival of the shipment outside the acceptable 2-day window with no reported adverse event; children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant patient of unknown age and demographics who received dose of HIB (PRP/T) vaccine [ACT-HIB] that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation). Information on the batch number was requested.  On an unknown date, a non-serious event arrival of the shipment outside the acceptable 2-day window with no reported adverse event (product storage error) (unknown latency), was reported.  On an unknown date, the patient developed a non-serious event children received doses of HIB (PRP/T) vaccine that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event (poor quality product administered) (latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event arrival of the shipment outside the acceptable 2-day window with no reported adverse event and was Unknown for the event children received doses of acthib that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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:  2023SA124713:
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: cold chain break is reported with no reported adverse event; poor quality vaccine administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an infant patient of unknown gender and it was reported cold chain break is reported for HIB (PRP/T) vaccine [ACT-HIB] and poor quality vaccine administered with no reported adverse event.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, cold chain break is reported for HIB (PRP/T) vaccine with no reported adverse event (product storage error) (unknown latency).  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection (batch/lot number: UJ756AAA, expiry date: 12-08-2023; strength, route: not reported) in unknown administration site for prophylactic vaccination (immunization) (poor quality product administered) (latency: same day).  It was reported that Act-HIB for which cold chain break is reported and excursion vaccine was administered to 30 children were within 2, 4, and 6 months of age. The order contained ActHib (10 boxes or 50 doses) and MenQuadfi (5 boxes or 25 doses). The order was delivered to the facility on 30Mar2023. The facility received email notification on 14Apr2023 at 14:30 that the products should not be used because they were delivered beyond the acceptable shipping time. It was stated that a big frustration is that Sanofi no longer has a cold chain tracker in the boxes. From the information I received, you have a term 'anticipated transaction date' which was 29Mar2023. That term means nothing to the clinical staff as far a cold chain failure. We had no idea this was a broken cold chain until two weeks after the shipment arrived. Because of that, 30 kids received the ActHib and 3 patients received MenQuadfi from this shipment.  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACTHIB was administered in which the diluent only was expired with no reported adverse event; Initial information received on 25-Apr-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 years old male patient who was administered expired HIB (PRP/T) vaccine [ACT-HIB] in which the diluent only was expired 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 A vaccine inact (Havrix) for Immunisation; and measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad) for Immunisation.  On 17-Apr-2023, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (batch: UJ739ABA; expiry date: 07-Apr-2023) via intramuscular route in the left vastus lateralis for Immunization in which the diluent only was expired with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired acthib was administered in which the diluent only was expired with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: received tenivac instead of boostrix with no reported adverse event; Initial information received on 25-Apr-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 28 years old female patient who received diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] instead of boostrix with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection lot number not reported via unknown route in unknown administration site (dose, frequency, strength and expiration date: not provided) for immunization.  On an unknown date the patient received tenivac instead of boostrix with no reported adverse event (wrong product administered) (latency- same day) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: U
Vaccine: DTAP
Symptoms: Contraindicated product administered, Medication error, No adverse event
Clinical narrative: patient received PENTACEL and DAPTACEL on the same day with no reported adverse event; Initial information received on 25-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 months old and unknown gender patient who received pentacel and diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] on the same day 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, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Prophylactic vaccination.  On an unknown date, the patient received unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On an unknown date the patient developed a non-serious event "patient received pentacel and daptacel on the same day with no reported adverse event (contraindicated product administered)" (unknown latency) following the administration of diphtheria-15/tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test positive
Clinical narrative: I had my vaccination on 04/29/2022. I tested COVID-19 Positive on 04/07/2023. I was prescribed Paxlovid. I am presently feeling ok but still have some fatigue on 05/01/2023.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bronchitis, Cough, Fatigue, Impaired work ability, Wheezing
Clinical narrative: In April, 2023, I felt like I had something going on in my chest. I began to have a dry, hacking cough. I got really tired and left work early. I went to urgent care on Tuesday, April 25, 2023. I was prescribed steroids and an inhaler. I was diagnosed with bronchitis based on a physical exam and evidence of wheezing.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: I tested positive for Covid-19 on April 2, 2023, I experienced fever of 103.0, chills, body aches, sneezing, runny nose, sore throat, I was prescribed PAXLOVID for my symptoms.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: I tested positive for Covid-19 on April 2, 2023, I experienced fever of 103.0, chills, body aches, sneezing, runny nose, sore throat, I was prescribed PAXLOVID for my symptoms.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Device defective, Pain in extremity, Rotator cuff repair, Rotator cuff syndrome
Clinical narrative: I had extreme pain in my right shoulder/arm within days of receiving this shot.
Age: 7.0
Sex: M
Vaccine: COVID19-2, FLU4, HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient given 0.2 mL dose of gray cap Pfizer Bivalent for 12years and older. Patients did not exhibit any adverse symptoms. Patient had no complaints prior to leaving post vaccinations area.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: PATIENT RECEIVED INITIAL COVID VACCINATION (PFIZER) 4/5/2023. SECOND COVID VACCINATION (BIVALENT MODERNA) WAS ADMINISTERED TODAY 5/1/2023, WHICH WAS GIVEN BEFORE THE MINIMUM 2 MONTH INTERVAL. CDC HOTLINE WAS CONTACTED AND RN WAS INFORMED THAT THE DOSE WOULD NEED TO BE REPEATED WITH A 2 MONTH INTERVAL STARTING TODAY WHEN THE INCORRECT DOSE WAS GIVEN. PATIENT WAS INFORMED AND AGREED TO COME IN FOR REPEAT DOSE 2 MONTHS FROM NOW.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The vaccine given was for >/= 18 yo
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site discolouration, Injection site macule, Macule, Vaccination site erythema, Vaccination site oedema
Clinical narrative: Onset within 24 hours of erythema, edema, tenderness at vaccine site with discoloration at injection area (black/blue circle with clustered erythematous macules) surrounded by 3x2 inch circular area of erythema and warmth. Plan to trial Motrin, elevation, and Claritin with referral to an allergist and close monitoring of symptoms.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Vaccination site pain
Clinical narrative: Onset within 24 hours of erythema, edema, tenderness at vaccine site with discoloration at injection area (black/blue circle with clustered erythematous macules) surrounded by 3x2 inch circular area of erythema and warmth. Plan to trial Motrin, elevation, and Claritin with referral to an allergist and close monitoring of symptoms.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Stomatitis
Clinical narrative: 4/4/23 I had a lesion on the roof of my mouth that would not go away. It was very painful. I could not eat or drink anything hot. I went to the dentist about a week later. He could not figure out what it was. He said to gargle with salt water and be careful with what you are eating. I stopped taking all dietary supplements. The lesion is still there. It has gotten better but has not gone away. I saw the dentist today. He said it has not gotten any smaller. I go see an oral surgeon next week for a biopsy to see what is going on.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: She came into our pharmacy today (05/01/2023) complaining of pain in her left shoulder. She said it developed several days after administration of Shingrix on February 1, 2023. It got progressively worse. She says she is in a lot of pain and can no longer raise her left arm. We notified her physician's office. They will be contacting her.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chest X-ray abnormal, Cough, Diaphragmatic disorder, Diarrhoea
Clinical narrative: 02/22/203, I felt generally poor, headache, fever and cough. I tested on 02/22/2022 with aCOVID-19 Home Test and the results were positive. The evening of the 02/22/2023, I went to an urgent care. They did an EKG, chest x-ray, and they prescribed a cough medicine, and I chose not to take the Paxlovid after I heard the pros and cons of taking it. After I started feeling better, I had a couple of days of diarrhea.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Electrocardiogram normal, Feeling abnormal, Headache, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 02/22/203, I felt generally poor, headache, fever and cough. I tested on 02/22/2022 with aCOVID-19 Home Test and the results were positive. The evening of the 02/22/2023, I went to an urgent care. They did an EKG, chest x-ray, and they prescribed a cough medicine, and I chose not to take the Paxlovid after I heard the pros and cons of taking it. After I started feeling better, I had a couple of days of diarrhea.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Atelectasis, Chest X-ray abnormal, Pneumonia, Secretion discharge
Clinical narrative: I caught something from someone not sure what it was , that let to pneumonia and then it went to infection in the lungs. I had mucus at the bottom of my lung, they changed my medication and gave me an inhaler.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse reaction to vaccine
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dysgeusia, Fatigue, SARS-CoV-2 test positive
Clinical narrative: At about 6:00 PM on one evening in September 2022, I experienced extreme exhaustion, which was stronger than my usual fatigue. This persisted until bedtime. During the night, I developed a severe, deep, nonproductive cough. The cough and fatigue lasted for about five days. For the first three days, the fatigue was extreme, and then it began to let up a bit afterwards. After the fifth day, I felt pretty close to normal again. On the second day of my symptoms, I took a home antigen test and got a positive result. I called my doctor and got a prescription for PAXLOVID, which I began taking that day. The cough lasted for maybe four or five days before it ended, and it remained nonproductive. I took PAXLOVID for the prescribed five days, and by the time I finished it, I felt pretty much normal again. The cough and the fatigue were gone. The PAXLOVID left a metallic aftertaste. I never lost my sense of taste or smell during my bout with COVID-19.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Autoimmune disorder, Blood test, Brain oedema, Brain stem syndrome, CSF test
Clinical narrative: Initially there was no reaction except soreness at the site. After about 6 weeks became lethargic which slowly increased over 6 months leading to numbness and tingling in hands, feet and slurring of speech.  went to several emergency rooms only to be sent home. In July 2022 finally admitted to local Health Services with unknown diagnosis. Went to alternate Clinic where it was diagnosed as autoimmune rhombencephilitis and hospice was recommended. Lifeflighted to 2nd. alternate facility for stem cell transplant. Currently in inpatient rehabilitation . Cannot walk, cannot use arms for eating dressing or grasping objects. Speech remains difficult.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dysarthria, Encephalitis brain stem, Gait inability, Hypoaesthesia, Injection site pain
Clinical narrative: Initially there was no reaction except soreness at the site. After about 6 weeks became lethargic which slowly increased over 6 months leading to numbness and tingling in hands, feet and slurring of speech.  went to several emergency rooms only to be sent home. In July 2022 finally admitted to local Health Services with unknown diagnosis. Went to alternate Clinic where it was diagnosed as autoimmune rhombencephilitis and hospice was recommended. Lifeflighted to 2nd. alternate facility for stem cell transplant. Currently in inpatient rehabilitation . Cannot walk, cannot use arms for eating dressing or grasping objects. Speech remains difficult.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Laboratory test, Lethargy, Loss of personal independence in daily activities, Magnetic resonance imaging, Motor dysfunction
Clinical narrative: Initially there was no reaction except soreness at the site. After about 6 weeks became lethargic which slowly increased over 6 months leading to numbness and tingling in hands, feet and slurring of speech.  went to several emergency rooms only to be sent home. In July 2022 finally admitted to local Health Services with unknown diagnosis. Went to alternate Clinic where it was diagnosed as autoimmune rhombencephilitis and hospice was recommended. Lifeflighted to 2nd. alternate facility for stem cell transplant. Currently in inpatient rehabilitation . Cannot walk, cannot use arms for eating dressing or grasping objects. Speech remains difficult.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Musculoskeletal disorder, Paraesthesia, Positron emission tomogram, Speech disorder, Stem cell transplant
Clinical narrative: Initially there was no reaction except soreness at the site. After about 6 weeks became lethargic which slowly increased over 6 months leading to numbness and tingling in hands, feet and slurring of speech.  went to several emergency rooms only to be sent home. In July 2022 finally admitted to local Health Services with unknown diagnosis. Went to alternate Clinic where it was diagnosed as autoimmune rhombencephilitis and hospice was recommended. Lifeflighted to 2nd. alternate facility for stem cell transplant. Currently in inpatient rehabilitation . Cannot walk, cannot use arms for eating dressing or grasping objects. Speech remains difficult.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Swelling, X-ray
Clinical narrative: Initially there was no reaction except soreness at the site. After about 6 weeks became lethargic which slowly increased over 6 months leading to numbness and tingling in hands, feet and slurring of speech.  went to several emergency rooms only to be sent home. In July 2022 finally admitted to local Health Services with unknown diagnosis. Went to alternate Clinic where it was diagnosed as autoimmune rhombencephilitis and hospice was recommended. Lifeflighted to 2nd. alternate facility for stem cell transplant. Currently in inpatient rehabilitation . Cannot walk, cannot use arms for eating dressing or grasping objects. Speech remains difficult.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Product preparation error
Clinical narrative: PATIENT CAME IN FOR VACCINES 09/20/2022, RN ONLY ADMINISTERED DILUENT. HIB COMPONENT WAS NOT MIXED IN. PATIENTS MOTHER WAS INFORMED AND CORRECT VACCINATION WAS ADMINISTERED 04/04/2023.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: Covid February 2/24/23 mild symptoms treated w/ paxlovid.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Fatigue, Headache, Sudden death
Clinical narrative: Extreme fatigue, extreme headache lasted two weeks resulted in Sudden death in sleep
Age: 13.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Blood bilirubin increased, Computerised tomogram normal, Electroencephalogram normal, Magnetic resonance imaging normal, Migraine
Clinical narrative: Persistent migraines and vertigo since vaccines given. Haven't gone away.
Age: 13.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Vertigo
Clinical narrative: Persistent migraines and vertigo since vaccines given. Haven't gone away.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Lymphadenopathy, Malaise
Clinical narrative: Left upper arm pain and swelling. Left axillary lymphadenopathy. Vesicular rash in axilla. Another patchy, erythematous rash on left upper arm. General malaise.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Rash vesicular
Clinical narrative: Left upper arm pain and swelling. Left axillary lymphadenopathy. Vesicular rash in axilla. Another patchy, erythematous rash on left upper arm. General malaise.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female, Breast conserving surgery, Mammogram, Ultrasound scan
Clinical narrative: diagnosed with breast cancer
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Balance disorder, Fall, Hyperhidrosis, Pallor
Clinical narrative: Received HPV and MCV earlier and on his way out of the visit.   After vaccines, walking out when noted by a nurse to be imbalanced.  Looked pale and fell to the floor of a room, but  no loss of consciousness or head injury.  He was awake and alert. Knew where he was, first and last name and birthdate.  First time receiving these vaccines. Per mom, had heavy later breakfast.  Not sure if had sufficient fluid intake today.     98/59 HR of 63-72 O2 96% on RA. Pale and diaphoretic but at baseline speech. Laid down for about 5 min on exam table. Color returned.  BP of about 110/60 prior to discharge.  Able to walk back out without issues.  No further tremors to face and extremities during this episode. No nystagmus. Attempted hi-five without tremors noted. Facial movements without tremors. Tolerated a few sips of water.  Able to convey he felt better and back to normal. Able to walk out of office on own.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Dysuria, Headache, Myalgia
Clinical narrative: Very bad headache, problem urinating, muscle pain, high fever, chills, nerve pain in back.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Pyrexia
Clinical narrative: Very bad headache, problem urinating, muscle pain, high fever, chills, nerve pain in back.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Injection site soreness (Day 1 - Day 5), full body aches (Day 2 - Day 4), intermittent chills (Day 2 - Day 4), mild headaches (Day 3), tiredness (Day 1 - Day 6), Dizziness (Day 6), some loss of balance (Day 6), treated with Ibuprofen (aches) and Aspirin (headaches).
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Injection site soreness (Day 1 - Day 5), full body aches (Day 2 - Day 4), intermittent chills (Day 2 - Day 4), mild headaches (Day 3), tiredness (Day 1 - Day 6), Dizziness (Day 6), some loss of balance (Day 6), treated with Ibuprofen (aches) and Aspirin (headaches).
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Asthenia, Balance disorder, Blood test, Computerised tomogram
Clinical narrative: Dizziness, vertigo, vomiting, tinnitus, heartbeat in ear, unbalanced, breaking out in a sweat, so sick can?t hold my head up, so weak can?t walk.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Gait inability, Hyperhidrosis, Magnetic resonance imaging, Malaise
Clinical narrative: Dizziness, vertigo, vomiting, tinnitus, heartbeat in ear, unbalanced, breaking out in a sweat, so sick can?t hold my head up, so weak can?t walk.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mobility decreased, Tinnitus, Vertigo, Vomiting
Clinical narrative: Dizziness, vertigo, vomiting, tinnitus, heartbeat in ear, unbalanced, breaking out in a sweat, so sick can?t hold my head up, so weak can?t walk.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Auscultation, Erythema, Rash, Rash macular, Rash papular
Clinical narrative: Within 1-2 minutes after receiving vaccines, I was notified by the medical assistant that patient was breaking out in a rash. I observed diffuse red splotchy lesions mostly flat with few raised areas. Areas of well demarcated erythema as well as faded borders noted. Largely covering thighs, arms, cheeks, forehead, and onto scalp. Pt was not scratching at skin. Lungs CTA, breathing comfortably. Administered Benadryl 2.5 mL at 9:55am and rash was near resolved by 10:15am.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Skin lesion
Clinical narrative: Within 1-2 minutes after receiving vaccines, I was notified by the medical assistant that patient was breaking out in a rash. I observed diffuse red splotchy lesions mostly flat with few raised areas. Areas of well demarcated erythema as well as faded borders noted. Largely covering thighs, arms, cheeks, forehead, and onto scalp. Pt was not scratching at skin. Lungs CTA, breathing comfortably. Administered Benadryl 2.5 mL at 9:55am and rash was near resolved by 10:15am.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: A Pfizer Bivalent vaccine was already administered to this individual on 9/22/22. at our office. We administered an additional pfizer bivalent vaccine on 4/28/23 by mistake. The individual who received the vaccines has not had any health issues.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: As soon as the vaccine was injected into my body, I started to experience joint pain. The pain is now in my hands (sharp, burning sensation like my hands are on fire) and bilateral knees radiating to my feet (achy, sharp pains).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: As soon as the vaccine was injected into my body, I started to experience joint pain. The pain is now in my hands (sharp, burning sensation like my hands are on fire) and bilateral knees radiating to my feet (achy, sharp pains).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines ; Pfizer 6/8/21 Lot# EW0186; Pfizer 6/29/21 Lot# Ew0196
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 13-month-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 16-FEB-2023, the patient was vaccinated at a private doctor's office/hospital with an improperly stored dose (reported as "temperature excursion", which occurred on 20-JAN-2023) of varicella virus vaccine live (Oka/Merck) (VARIVAX) (product storage error) in his right thigh as prophylaxis (lot # W006412, which had been verified to be a valid lot number and expiration date was reported and confirmed upon internal validation as 23-FEB-2024; dose and route of administration were not provided). Temperature excursion details: total time in the range of 6 Degree Fahrenheit (°F) to 14°F (-14 Degree Celsius (°C) to -10°C): 1 hour, total combine excursion time: 1 hour, 0 minutes, 0 seconds as recorded by a data logger. No adverse events occurred. No PQC.  This is one of several cases received from the same reporter (original case #2303USA002114).; Sender's Comments:  US-009507513-2304USA007931: US-009507513-2304USA007889: US-009507513-2304USA007686:
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; PROQUAD was administered to a 17 year old patient .; This spontaneous report was received from Other Health Professional and refers to a 17-year-old patient.  Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On an unknown date, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W029547, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age). No other adverse event. No product quality complaint.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs reported; expired dose of PNEUMOVAX 23 was administered; This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-APR-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe injection, at a dose of 0.5 milliliter, lot #U026796, expiration date: 28-JAN-2023, administered intramuscularly for prophylaxis (anatomical location was not provided) (expired product administered).  No additional adverse event was reported.