chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Asthenia, Fatigue, Hypoaesthesia oral, Lip swelling, Pyrexia
Clinical narrative: On 11/17/23 I experienced a slight fever, fatigue and weakness throughout the day.  On Saturday evening 11/18/23  and during the day on Sunday 11/19/23, I experienced rashes on my arms, legs and trunk in the form of red, itchy spots and raised areas that had not blistered. In addition, I experienced swelling and numbness in my lips.  The swelling in my lips lasted un til Monday, 11/19/23.  I was able to manage the condition through topical application of Benadryl on my skin and through taking Benadryl orally.  On 11/19/23 I was prescribed Prednisone 20mg, to be taken daily for 5 days, and loratadine 10 mg, to be taken daily for 30 days.  The symptoms have abated.
Age: 66.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: On 11/17/23 I experienced a slight fever, fatigue and weakness throughout the day.  On Saturday evening 11/18/23  and during the day on Sunday 11/19/23, I experienced rashes on my arms, legs and trunk in the form of red, itchy spots and raised areas that had not blistered. In addition, I experienced swelling and numbness in my lips.  The swelling in my lips lasted un til Monday, 11/19/23.  I was able to manage the condition through topical application of Benadryl on my skin and through taking Benadryl orally.  On 11/19/23 I was prescribed Prednisone 20mg, to be taken daily for 5 days, and loratadine 10 mg, to be taken daily for 30 days.  The symptoms have abated.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Swelling and a red rash at the injection site, and fevers the next day when she woke up.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given the wrong dose of the COVID-19 vaccine.  Patient has no  symptoms.   I was distracted and grabbed the dose for the wrong age group.
Age: 59.0
Sex: F
Vaccine: COVID19, FLUR4, RSV, VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse event reported by the patient. The provider gave the RSV vaccine to a patient 59 years of age. The vaccine is given to those age 60+.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site pruritus
Clinical narrative: Patient experienced headache, fever, chills, and severe fatigue. A rash developed at the injection site and was itchy and painful.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Patient experienced headache, fever, chills, and severe fatigue. A rash developed at the injection site and was itchy and painful.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Patient is  experiencing extreme arm pain down arm.   This has been occurring for over 3 weeks.  Have tried Tylenol, ice pack, lidocaine patch, still hurting
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient had sore arm shortly after she received vaccine. Patient stated she was not getting full range of motion so went to chiropractor on 11/10/23 and some relief occurred. Followed up with primary on 11/20/23 and said range of motion was due to administration technique. Patient will be following up with physical therapy.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: I did not administer this vaccine, I am reporting as the pharmacy manager of the location that provided the vaccine. Patient received a flu vaccine at a clinic held at her place of employment. Shortly after receiving the vaccine, she came back to the pharmacist and reported that her arm was feeling "tingly." The pharmacist informed her that it is likely nothing to worry about, but to apply ice if she is uncomfortable and to take pain relievers if it starts to become sore, and to monitor for any changes. A few days later, the patient contacted her physician because the sensation was still there, and her physician recommended she contact the pharmacy. So she got in contact with the pharmacist that held the clinic with her concerns. He informed her that this can happen if the vaccine was given near a nerve, causing the nerve and the surrounding area to become inflamed which could cause her symptoms. He told her that we would report to VAERS and for her to continue to monitor and to follow up with us with any changes.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Child requires several catch up doses of vaccines by Recommendations.  Trying to spare the child even more shots I administered a dose of Pediarix.  While doing  inventory 11/21/23 it was discovered the Pediarix Vaccine actually expired on 11/17/23.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Electromyogram normal, Hypoaesthesia, Nerve conduction studies normal, Paraesthesia
Clinical narrative: Developed Small Fiber Neuropathy which started in January 2023 and continues to present.  Tingling and numbness in my feet, lower legs and fingers.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Small fibre neuropathy
Clinical narrative: Developed Small Fiber Neuropathy which started in January 2023 and continues to present.  Tingling and numbness in my feet, lower legs and fingers.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Patient is still experiencing severe arm pain several weeks after her injection.  (Husband got one day prior also having pain) different day, different immunizer - She has tried tylenol, ice pack, lidocaine patch and still experiencing this pain.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: That evening (11/14) and the next day the pt experienced severe generalized weakness, that diminished over time lasting about 5 days.  Pt able to call for medical attention on 11/15 but refused transport to any medical facility as she was told all of her vitals were normal.  Pt was asked but did not experience any muscle pain, or fever, or Nausea or vomiting.
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Few minutes after getting the vaccine, patient lost consciousness while seated.  She was put into recovery position and experienced what appeared to be a very transient seizure. she was sweaty and pale. after approximately a minute of that happening, she re-gained consciousness. Patient stated that she was fine. however, she was informed that she experienced a transient seizure, although she didn't report any seizure history. EMS was called and it appears that patient chose not to go to the hospital. She left the pharmacy with her parent.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Rendering provider during appointment ordered Hep A (Vaqta) adult vaccine which was administered by writer/medical assistant near end of visit. Further treatment and outcomes unknown by writer.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Blister, Erythema, Pustule
Clinical narrative: 2 blisters on arm with posture in center of each, redness around outside
Age: 77.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Wrong product administered
Clinical narrative: I have not had an adverse reaction. I am reporting that my husband and I asked for a Covid vaccine at Pharmacy 10/10/23. We were told Pfizer was available and we agreed. Later when we went to another pharmacy for an influenza vaccine we were told the records showed we had received both a Covid vaccine and an influenza vaccine. We are sure we only received one vaccine. I do not know if I have filled in the names of the vaccines correctly above but the lot numbers are correct. Now we are not sure which vaccine we received. We want to be sure we are as protected as possible.
Age: 74.0
Sex: M
Vaccine: FLUA4, VARZOS
Symptoms: Magnetic resonance imaging normal, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Patient reported to the pharmacy complaining of stiffness and swelling in the left arm following vaccination.  He was seem at the ER and had an MRI.  He stated  the MD told him that there was nothing remarkable on the report and did not give a reason for the complaint of the patient
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: right eyelid swelling  for one day
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Laboratory test, Pruritus, Swelling face
Clinical narrative: Several days after vaccination pt began having swelling and redness to face.  Over next week symptoms worsen to extreme swelling and redness of face, redness to neck, itchiness of legs.  Pt used steroid cream with some relief.  Symptoms took approximately three weeks to resolve.  This was pt's 6th covid vaccine.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Nausea, Pain, Vomiting
Clinical narrative: Severe nausea for 6+ hours, followed by vomiting. Body aches and fatigue lasting 24 hours. Onset of symptoms began 3-4 hours after vaccination and lasted approximately 24 hours.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reporting on day 4 after immunization, arm soreness, redness and warmth at injection site.  Patient states it appears to be getting better.
Age: 58.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: DISPENSED FROM PHARMACY, BUT PHARMACY DID NOT ADMINISTER VACCINE. ADMINISTERED BY HOME HEALTH CARE NURSE.  Technician grabbed wrong patient's vaccine bag (same last name), gave bag to home health care nurse, and home health care nurse vaccinated patient with high-dose flu shot without checking patient name on bag. Patient was to receive regular quadrivalent flu shot, but recieved high-dose flu shot instead. No adverse drug events to report at this time.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Loss of consciousness, Unresponsive to stimuli, Vision blurred
Clinical narrative: Patient passed out after receiving COVID XBB booster and Fluzone vaccines. Patient stated he felt light headed, had difficulty seeing/blurred vision, and became unresponsive.  Legs elevated with assistance. Once responsive and regained balance,  pt was transferred to stretcher for monitoring. MD notified of symptoms. Juice and crackers offered. Discharged to home once stable and asymptomatic.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness for more than 4 days
Age: 63.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Erythema
Clinical narrative: Approximately a month after vaccine, patient noticed a large red area on upper right arm, which then developed into a darkened and thickend area, approx 3cm x 3cm a few days later.
Age: 14.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Blood glucose normal, Hypotension, Lip swelling, Syncope
Clinical narrative: After the vaccines were administered patient started fainting while was on the chair. Dad held him and he was conscious and awake. his lips started swelling. Father requested to call paramedics. when they came in they check his Sugar level it was 104. his blood pressure was low and few minutes later it was normal according to the paramedics. Patient came in without breakfast
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Dizziness, Dysstasia, Fatigue, Feeling cold
Clinical narrative: I have never had a reaction to any vaccines. I was out that night after the vaccine and I was starting to feel SO cold, I get into bed and I turned on my heating blanket and I was convulsively shivering/shaking and I had chills and I could not get warm at all for about 1-1.5 hours. I try to get up around 2 am to use the bathroom, I am sitting on the edge of my bed and felt like I would pass out. I was so dizzy I couldn't stand up. I finally pushed myself up and held myself up on the wall and I was very nauseated and felt like passing out. I am sitting on the toilet and I am there for 30 minutes or so and thinking I need to call someone. I tried to get up but ended up having to crawl back to my bed. I was scared to fall asleep. I layed in bed and finally slept. When I woke up, I felt really drugged but the feeling of passing out was gone. I felt like I had taken a sleeping pill or something. After that I had extreme fatigue and my husband even said I looked "stoned".  I am doing fine now.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Gait disturbance, Hangover, Nausea, Tremor
Clinical narrative: I have never had a reaction to any vaccines. I was out that night after the vaccine and I was starting to feel SO cold, I get into bed and I turned on my heating blanket and I was convulsively shivering/shaking and I had chills and I could not get warm at all for about 1-1.5 hours. I try to get up around 2 am to use the bathroom, I am sitting on the edge of my bed and felt like I would pass out. I was so dizzy I couldn't stand up. I finally pushed myself up and held myself up on the wall and I was very nauseated and felt like passing out. I am sitting on the toilet and I am there for 30 minutes or so and thinking I need to call someone. I tried to get up but ended up having to crawl back to my bed. I was scared to fall asleep. I layed in bed and finally slept. When I woke up, I felt really drugged but the feeling of passing out was gone. I felt like I had taken a sleeping pill or something. After that I had extreme fatigue and my husband even said I looked "stoned".  I am doing fine now.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia, Injection site induration, Injection site mass, Pain
Clinical narrative: Pt stated her arm got a hard lump at the injection site followed by a red ring around the vaccination area.  Also stated she experienced pain/ numbness that radiated down her arm. Went to Hospital to get an ultrasound to check for infection. Pt states no infection was found and doctors told her it was a bad allergic reaction to the vaccine.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound scan normal, Vaccination site erythema
Clinical narrative: Pt stated her arm got a hard lump at the injection site followed by a red ring around the vaccination area.  Also stated she experienced pain/ numbness that radiated down her arm. Went to Hospital to get an ultrasound to check for infection. Pt states no infection was found and doctors told her it was a bad allergic reaction to the vaccine.
Sex: F
Vaccine: FLU4
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Patient stated they have a headache. Continued to get vaccine. Patient waited after vaccines; no reactions occurred at that time. Left the store and when elsewhere and patient passed out and hit head.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE and no PQC; expired dose of GARDASIL 9 to a patient on 10/19/2023; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 19-OCT-2023, the patient was vaccinated with an expired dose (1 dosage form) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation Prefilled syringe, lot # U008899 with expiration date: 12-AUG-2023, strength and route were unknown) for prophylaxis (expired product administered). Operator of device was health professional. The reporter confirmed no previous temperature excursions for the suspect product and stored in the recommended range. There are no symptoms or further details to report. The reporter requested if the administration period was supported beyond the labeled expiry. No other adverse event and no product quality complaints.
Age: 71.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No side effects were reported/No other additional AEs/no PQC.; HCP calling to report an adult received a pediatric dose of VAQTA inadvertently.; This spontaneous report was received from a Registered Nurse referring to a 71-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications was not reported.  On 24-OCT-2023, the patient was vaccinated inadvertently with a pediatric dose (0.5 milliliters) of Hepatitis A Vaccine, Inactivated (VAQTA) (lot # W023937 has been verified to be a valid lot number, expiration date 06-DEC-2023) (Incorrect dose administered) (strength, dose number, route of administration and anatomical location were not provided) administered as prophylaxis. No side effects was reported.
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Diarrhoea, Incorrect route of product administration, Injection site rash
Clinical narrative: PROQUAD Route Of Administration IV; The patient experienced diarrhea; The patient experienced rash on injection site; This spontaneous report was received from an other health care professional (HCP), concerning a male patient of unknown age. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies.  On 27-OCT-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) administered intravenously (incorrect route of product administration), therapy type: rHA, lot number: X018581 and expiration date: 05-JAN-2025 (dosage regimen, strength, dose, anatomical location) for prophylaxis; and with diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX).   On that day, the patient experienced diarrhea and a rash on injection site later that day. It was stated patient experienced symptoms for 3 days. Reporter stated patient went to HCP on 30-OCT-2023, for follow up. At the time of the report, the outcome of the events was unknown.  The causal relationship between events and the suspect vaccines was unknown; however, HCP stated diarrhea may be caused by separate virus that was not known at the time and may not had been from the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) vaccine.
Age: 0.33
Sex: M
Vaccine: MMR, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: HCP has no further AE information; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; This spontaneous report was received from a medical assistant concerning to an approximately 4-month-old (also reported as 5-month-old) male patient.  Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 19-SEP-2023, according to a digital data logger, there was a temperature excursion in clinical practice at 9:28, temperature was 8.3 Celsius degree and at 10:02 the temperature was 7.5 (units not provided) for a total excursion time of 34 minutes for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number reported as 1933911 (expiration date 18-APR-2024) and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot  number reported as W001598 (expiration date 14-JAN-2024), albumin status was not provided, however, upon internal validation it was stablished as rHA. On 20-SEP-2023, the patient received the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, and route of administration were not provided) and the improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, and route of administration were not provided) (product administered to patient of inappropriate age) (product storage error) both of them administered as prophylaxis. It was reported that the patient received the vaccination in a private doctor's office.  No adverse effect was observed (no adverse event). On 25-SEP-2023 at 11:08 temperature was at 9 Celsius degree and at 15:01 it was at 8.0 Celsius degree, for a total excursion time of 4 hours.       This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA002929: US-009507513-2311USA002928: US-009507513-2311USA002927: US-009507513-2310USA010775: US-009507513-2311USA002932: US-009507513-2311USA002930: US-009507513-2311USA002931: US-009507513-2311USA003147:
Age: 0.5
Sex: M
Vaccine: MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP has no further AE information; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; This spontaneous report was received from a medical assistant concerning to an approximately 6-month-old (also reported as 7-month-old) male patient.  Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 19-SEP-2023, according to a digital data logger, there was a temperature excursion in clinical practice at 9:28, temperature was 8.3 Celsius degree and at 10:02 the temperature was 7.5 (units not provided) for a total excursion time of 34 minutes for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number reported as 1933911 (expiration date 18-APR-2024) and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot  number reported as W001598 (expiration date 14-JAN-2024), albumin status was not provided, however, upon internal validation it was stablished as rHA. On 25-SEP-2023 at 11:08 temperature was at 9 Celsius degree and at 15:01 it was at 8.0 Celsius degree, for a total excursion time of 4 hours.  On 06-OCT-2023, the patient received the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, and route of administration were not provided) and the improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, and route of administration were not provided) (product administered to patient of inappropriate age) (product storage error) both of them administered as prophylaxis. It was reported that the patient received the vaccination in a private doctor's office.  No adverse effect was observed (no adverse event).     This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA002926: US-009507513-2310USA010775: US-009507513-2311USA003147: US-009507513-2311USA002932: US-009507513-2311USA002931: US-009507513-2311USA002929: US-009507513-2311USA002930: US-009507513-2311USA002928:
Age: 0.42
Sex: M
Vaccine: MMR, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: HCP has no further AE information; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; This spontaneous report was received from a medical assistant concerning to a 5-month-old male patient.  Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 19-SEP-2023, according to a digital data logger, there was a temperature excursion in clinical practice at 9:28, temperature was 8.3 Celsius degree and at 10:02 the temperature was 7.5 (units not provided) for a total excursion time of 34 minutes for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number reported as 1933911 (expiration date 18-APR-2024) and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot  number reported as W001598 (expiration date 14-JAN-2024), albumin status was not provided, however, upon internal validation it was stablished as rHA. On 25-SEP-2023 at 11:08 temperature was at 9 Celsius degree and at 15:01 it was at 8.0 Celsius degree, for a total excursion time of 4 hours. On 11-OCT-2023, the patient received the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, and route of administration were not provided) and the improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, and route of administration were not provided) (product administered to patient of inappropriate age) (product storage error) both of them administered as prophylaxis. It was reported that the patient received the vaccination in a private doctor's office.  No adverse effect was observed (no adverse event).     This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA002926: US-009507513-2310USA010775: US-009507513-2311USA003147: US-009507513-2311USA002927: US-009507513-2311USA002928: US-009507513-2311USA002929: US-009507513-2311USA002931: US-009507513-2311USA002932:
Age: 0.33
Sex: F
Vaccine: MMR, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: HCP has no further AE information; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; This spontaneous report was received from a medical assistant concerning to an approximately 4-month-old (also reported as 5-month-old) female patient.  Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 19-SEP-2023, according to a digital data logger, there was a temperature excursion in clinical practice at 9:28, temperature was 8.3 Celsius degree and at 10:02 the temperature was 7.5 (units not provided) for a total excursion time of 34 minutes for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number reported as 1933911 (expiration date 18-APR-2024) and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot  number reported as W001598 (expiration date 14-JAN-2024), albumin status was not provided, however, upon internal validation it was stablished as rHA. On 20-SEP-2023, the patient received the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, and route of administration were not provided) and the improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, and route of administration were not provided) (product administered to patient of inappropriate age) (product storage error) both of them administered as prophylaxis. It was reported that the patient received the vaccination in a private doctor's office.  No adverse effect was observed (no adverse event). On 25-SEP-2023 at 11:08 temperature was at 9 Celsius degree and at 15:01 it was at 8.0 Celsius degree, for a total excursion time of 4 hours.     This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA002926: US-009507513-2310USA010775: US-009507513-2311USA003147: US-009507513-2311USA002932: US-009507513-2311USA002930: US-009507513-2311USA002929: US-009507513-2311USA002928: US-009507513-2311USA002927:
Age: 1.08
Sex: M
Vaccine: MMR, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: HCP has no further AE information; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; This spontaneous report was received from a medical assistant concerning to a 13-month-old male patient.  Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 19-SEP-2023, according to a digital data logger, there was a temperature excursion in clinical practice at 9:28, temperature was 8.3 Celsius degree and at 10:02 the temperature was 7.5 (units not provided) for a total excursion time of 34 minutes for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number reported as 1933911 (expiration date 18-APR-2024) and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot  number reported as W001598 (expiration date 14-JAN-2024), albumin status was not provided, however, upon internal validation it was stablished as rHA. On 25-SEP-2023 at 11:08 temperature was at 9 Celsius degree and at 15:01 it was at 8.0 Celsius degree, for a total excursion time of 4 hours. On 29-SEP-2023, the patient received the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, and route of administration were not provided) (product administered to patient of inappropriate age) and the improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, and route of administration were not provided) (product storage error) both of them administered as prophylaxis. It was reported that the patient received the vaccination in a private doctor's office.  No adverse effect was observed (no adverse event).     This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA002926: US-009507513-2310USA010775: US-009507513-2311USA003147: US-009507513-2311USA002927: US-009507513-2311USA002928: US-009507513-2311USA002929: US-009507513-2311USA002930: US-009507513-2311USA002931:
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No other AE; HBP calling to report an inadvertent administration of PROQUAD and VARIVAX to a patient on the same day.  HBP reporting a patient received both vaccines on 11/02/2023.  This was the first dose of both vaccines for this patient.; This spontaneous report was received from a nurse concerning a 12-month-old patient of unknown gender. The patient's concurrent condition, medical history, and concomitant medication were not provided.  On 02-NOV-2023, the patient was inadvertently vaccinated with the first dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin [rHA]) (PNEUMOVAX) injection (lot# W038809, expiry date: 04-JUN-2024; dose, route of administration and anatomical location not provided) and with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot# W024334, expiry date: 01-AUG-2024; dose, route of administration and anatomical location not provided); both as prophylaxis (accidental overdose). There were no symptoms or additional details provided. There was no other adverse event (AE) (no adverse event).
Sex: F
Vaccine: PNC15, PPV
Symptoms: Arthritis, Brain fog, Condition aggravated, Dizziness, Drug ineffective
Clinical narrative: migraines or migraine after migraine; eczema or gotten worse is eczema; Joints got more inflamated; Had flare up of symptoms or mast cells still overreact; 25 mg didnt really do much or it never helped like a ton; brain fog; Headaches; I get very tired or getting pretty tired or I'm just so fatigued or fatigue; Dizziness; Hag gotten the pneumonia vaccine and had flare up symptoms/ wondering if it was an inflammatory response from the vaccine; higher triptase levels or increase in tryptase; Inflammation or excessive inflammatory response or inflammatory response after most vaccines or inflammation; This spontaneous report has been received from a physician and refers to a 48-year-old female patient.  The patient's pertinent medical history was not reported. The patient's concurrent conditions included  indolent systemic mastocytosis and systemic mastocytosis. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with either pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, or pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered for immunisation (strength, dose description, lot #, expiry date, and route of administration were not provided). On an unknown date in May 2022, the patient started therapy with avapritinib (AYVAKIT), 25 milligram, 1 per 1 day, administered orally for systemic mastocytosis and indolent systemic mastocytosis (strength, formulation, lot #, and expiry date were not provided).  On an unknown date (also reported as 4 days later), the patient experienced a flare-up of the symptoms migraine, eczema, joints got more inflamed (arthritis), flare up of symptoms or mast cells still overreact (condition aggravated), the 25 milligrams (mg) didnt really do much or it never helped like a ton (drug ineffective), brain fog, headaches (headache), the patient was feeling very tired or getting pretty tired or fatigued (fatigue), dizziness, the patient was wondering if it was an inflammatory response from the vaccine (immune reaction), she also presented higher triptase levels or increase in tryptase (tryptase increased), and inflammation or excessive inflammatory response (inflammation). At the time of reporting, the patient had not recovered from the event migraine, the outcome of the events headache, eczema, tryptase increased, inflammation, brain fog, arthritis, immunization reaction, condition aggravated and drug ineffective was not provided.The patient was recovering from the events fatigue and dizziness.  The reporter considered all events to be related to the suspect therapies.
Sex: F
Vaccine: PNC15, PPV
Symptoms: Eczema, Fatigue, Headache, Inflammation, Migraine
Clinical narrative: migraines or migraine after migraine; eczema or gotten worse is eczema; Joints got more inflamated; Had flare up of symptoms or mast cells still overreact; 25 mg didnt really do much or it never helped like a ton; brain fog; Headaches; I get very tired or getting pretty tired or I'm just so fatigued or fatigue; Dizziness; Hag gotten the pneumonia vaccine and had flare up symptoms/ wondering if it was an inflammatory response from the vaccine; higher triptase levels or increase in tryptase; Inflammation or excessive inflammatory response or inflammatory response after most vaccines or inflammation; This spontaneous report has been received from a physician and refers to a 48-year-old female patient.  The patient's pertinent medical history was not reported. The patient's concurrent conditions included  indolent systemic mastocytosis and systemic mastocytosis. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with either pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, or pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered for immunisation (strength, dose description, lot #, expiry date, and route of administration were not provided). On an unknown date in May 2022, the patient started therapy with avapritinib (AYVAKIT), 25 milligram, 1 per 1 day, administered orally for systemic mastocytosis and indolent systemic mastocytosis (strength, formulation, lot #, and expiry date were not provided).  On an unknown date (also reported as 4 days later), the patient experienced a flare-up of the symptoms migraine, eczema, joints got more inflamed (arthritis), flare up of symptoms or mast cells still overreact (condition aggravated), the 25 milligrams (mg) didnt really do much or it never helped like a ton (drug ineffective), brain fog, headaches (headache), the patient was feeling very tired or getting pretty tired or fatigued (fatigue), dizziness, the patient was wondering if it was an inflammatory response from the vaccine (immune reaction), she also presented higher triptase levels or increase in tryptase (tryptase increased), and inflammation or excessive inflammatory response (inflammation). At the time of reporting, the patient had not recovered from the event migraine, the outcome of the events headache, eczema, tryptase increased, inflammation, brain fog, arthritis, immunization reaction, condition aggravated and drug ineffective was not provided.The patient was recovering from the events fatigue and dizziness.  The reporter considered all events to be related to the suspect therapies.
Sex: F
Vaccine: PNC15, PPV
Symptoms: Tryptase increased
Clinical narrative: migraines or migraine after migraine; eczema or gotten worse is eczema; Joints got more inflamated; Had flare up of symptoms or mast cells still overreact; 25 mg didnt really do much or it never helped like a ton; brain fog; Headaches; I get very tired or getting pretty tired or I'm just so fatigued or fatigue; Dizziness; Hag gotten the pneumonia vaccine and had flare up symptoms/ wondering if it was an inflammatory response from the vaccine; higher triptase levels or increase in tryptase; Inflammation or excessive inflammatory response or inflammatory response after most vaccines or inflammation; This spontaneous report has been received from a physician and refers to a 48-year-old female patient.  The patient's pertinent medical history was not reported. The patient's concurrent conditions included  indolent systemic mastocytosis and systemic mastocytosis. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with either pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, or pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered for immunisation (strength, dose description, lot #, expiry date, and route of administration were not provided). On an unknown date in May 2022, the patient started therapy with avapritinib (AYVAKIT), 25 milligram, 1 per 1 day, administered orally for systemic mastocytosis and indolent systemic mastocytosis (strength, formulation, lot #, and expiry date were not provided).  On an unknown date (also reported as 4 days later), the patient experienced a flare-up of the symptoms migraine, eczema, joints got more inflamed (arthritis), flare up of symptoms or mast cells still overreact (condition aggravated), the 25 milligrams (mg) didnt really do much or it never helped like a ton (drug ineffective), brain fog, headaches (headache), the patient was feeling very tired or getting pretty tired or fatigued (fatigue), dizziness, the patient was wondering if it was an inflammatory response from the vaccine (immune reaction), she also presented higher triptase levels or increase in tryptase (tryptase increased), and inflammation or excessive inflammatory response (inflammation). At the time of reporting, the patient had not recovered from the event migraine, the outcome of the events headache, eczema, tryptase increased, inflammation, brain fog, arthritis, immunization reaction, condition aggravated and drug ineffective was not provided.The patient was recovering from the events fatigue and dizziness.  The reporter considered all events to be related to the suspect therapies.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC reported.; Nurse called and reported that a dose of VARIVAX was administered to a patient after a temperature excursion. Caller stated the dose was administered on 10/4/2023 and the product had 1 temperature excursion prior being administered. Caller stated pat; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 04-OCT-2023, the first dose of varicella virus vaccine live (oka/merck) (VARIVAX)  (lot number W031810 has been verified to be valid, expiration date 05-OCT-2024) (route and anatomical location were not reported) was administered as prophylaxis to a patient after a temperature excursion. Also the vaccine had 1 temperature excursion prior being administered. Caller stated patient had not reported any symptoms.   Moreover it was reported that the temperature: 10F, with yime frame: 1 Hour 15 Minutes 0 Seconds with no previous temperature excursion.
Sex: F
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: a patient who had seizures after receiving GARDASIL 9.; This spontaneous report was received from a Company Representative who reported on behalf of pharmacist, and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), (strength, dose, dose#, lot #, expiry date, route of administration, and anatomical site of vaccination were not provided) for prophylaxis.  The pharmacist stated that the patient came to her pharmacy to fill a prescription for an unspecified seizure medication, and the patient stated that on an unknown date,  she getting seizure after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), at her doctor's office. Due to the event, she received an unspecified seizure medications. At the time of reporting, the outcome of the event was unknown.  The causal relationship between seizures and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   Upon internal review, the event of seizure was determined to be medically significant.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Received a Dose of HEPLISAV-B Subcutaneously; Initial report received on 28-Jul-2023 and 01-Aug-2023  A lab supervisor reported that a male in his early 50's (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization subcutaneously.  No medical history, allergies, or concomitant medications were reported.   On 26-Jul-2023, the patient received the first dose of HEPLISAV-B (Lot # 943241, expiration date 06 Sep 2025, and NDC # unknown) subcutaneously in the left bicep using a 25-guage needle, which "did not go deep enough." The lab services supervisor administered the dose. No adverse reactions were reported.   No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea infectious
Clinical narrative: Traveler's diarrhea; A spontaneous report was received from a pharmacist on 02NOV2023 regarding a male patient of unknown age who had "traveler's diarrhea" (PT: Diarrhoea infectious) following the administration of oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On 26OCT2023, the patient took the first dose of Vivotif and then had traveler's diarrhea. Reportedly, the patient stopped Vivotif during the weekend.   The outcome of the reported event was unknown, at the time of this report.  The action taken with Vivotif with respect to the reported event was withdrawn.  No additional information was reported.  Company comment: It was reported that a male patient received first dose of Vivotif for immunisation and then had traveler's diarrhea. Vivotif was stopped in response to the above event. Considering the above information and strong temporal association, the causality of the above event is assessed as possible to Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a male patient received first dose of Vivotif for immunisation and then had traveler's diarrhea. Vivotif was stopped in response to the above event. Considering the above information and strong temporal association, the causality of the above event is assessed as possible to Vivotif. The case is considered non-serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Infection, Therapy cessation
Clinical narrative: Infection; Took only one capsule of Vivotif and doctors made the patient stop the vaccine; Took only one capsule of Vivotif and doctors made the patient stop the vaccine; A spontaneous report was received from a patient of unknown age and gender on 07NOV2023 who "took only one capsule of Vivotif and doctors made the patient stop the vaccine" (PT: Incomplete course of vaccination and PT: Therapy cessation) for an "infection" (PT: Infection). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: 3003851) for an immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient started the Vivotif vaccine protocol and took only the first dose and then had an infection. Reportedly, the treating physician made the patient stop the medication.  The outcome for the event "took only one capsule of Vivotif and doctors made the patient stop the vaccine" was not applicable and for event "infection" it was unknown.  The action taken with Vivotif with respect to the event "infection" was withdrawn and it was not applicable for event "took only one capsule of Vivotif and doctors made the patient stop the vaccine".  No additional information was reported.  Company comment: This case concerns a patient of unknown age and gender who took only one capsule of Vivotif and doctors made the patient stop the vaccine (incomplete course of vaccination and therapy cessation) for an infection (infection NOS). This case lacks information on the event of infection, start date, and relevant medical history of the patient. Hence, the causality for the event of infection NOS is not assessable until further information is received.  The causality for the events of incomplete course of vaccination and therapy cessation is assessed as not applicable considering the nature of the events.; Sender's Comments: This case concerns a patient of unknown age and gender who took only one capsule of Vivotif and doctors made the patient stop the vaccine (incomplete course of vaccination and therapy cessation) for an infection (infection NOS). This case lacks information on the event of infection, start date, and relevant medical history of the patient. Hence, the causality for the event of infection NOS is not assessable until further information is received.  The causality for the events of incomplete course of vaccination and therapy cessation is assessed as not applicable considering the nature of the events.