chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Accidental exposure to product, Exposure via skin contact, No adverse event
Clinical narrative: after the vaccines were administered the vaccine roll over her skin, with no adverse event; after the vaccines were administered the vaccine roll over her skin, with no adverse event; Initial information received on 19-Apr-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 15 months old female patient and it was reported after the Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] were administered the vaccine roll over her skin, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Apr-2024, the patient received dose 4 of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (with an unknown strength, expiry date, lot number) via unknown route in unknown administration site for immunization.  On 18-Apr-2024, after the Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] were administered to patient the vaccine roll over her skin, with no adverse event (accidental exposure to product) (exposure via skin contact) (latency: same day).   It was reported, stated her daughter was administered fourth dose of DAPTACEL and ACTHIB on 18APR2024. She is unsure if it was just a few drops. The medical assistant told caregiver that it was not unusual for that to happen. She asked for information regarding underdose and appropriate follow-up. She asked for information if vaccine was re-administered . No additional information available.  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: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Age: 17.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Medication Error. The wrong formulation of vaccine was administered for the patient's age, should have been Tdap instead. There was no adverse reaction.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Blood lead, Flushing, Haemoglobin normal, Rash
Clinical narrative: Patient received Hep A,  HIB, PCV20, Varicella, MMR in office. MOC was concerned as patient developed flushing of both cheeks 10-15 minutes after administration. Patient noted to be afebrile, vitals stable, no evidence of wheezing/breathing difficulty, rash was isolated to BL cheeks. Patient was observed in office for 30 minutes, noted to be well-appearing, active, without change in mental status.  -Allergy referral placed for reaction to vaccine  -Reassurance provided
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, No adverse event, Product storage error
Clinical narrative: Pfizer covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, No adverse event, Product storage error
Clinical narrative: Pfizer covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Loss of consciousness, Muscle contractions involuntary
Clinical narrative: Suffered a grand mal seizure while driving. According to witness, patient became unconscious and had uncontrolled muscle contractions. Seizure lasted about two-three minutes. Witness was able to slow car down and pull over. Patient woke up 15 minutes later on the sidewalk. Immediately transported to nearest hospital.
Age: 15.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Dyskinesia, Eye movement disorder
Clinical narrative: Patient was given hep B, IPV, MMR, varicella, and Tdap for the first time in our clinic  on 3/21/24. He immigrated and did not have his vaccine records (and mom was not sure if what vaccines he had received before) but serology showed patient was not immune to any of the given vaccines. Per mom, 2 days after patient received these vaccines, the patient was lying down at home when suddenly developed jerking movements of bilateral UE and eyes rolled back. This lasted about 1 minute. Patient was back to baseline immediately after, did not seem confused or excessively sleepy. No urinary incontinence or tongue biting during episode. This has never happened before. No family history of seizures. No associated fever or sick sxs around time of event. Patient did not seek medical care after this event.
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No Adverse events or outcomes. Asymptomatic. In summary: Patient was incorrectly given a higher dose of the Pfizer Covid-19 vaccine for their age group. Patient is 2 years old and received the age > 5 vaccine dose instead. Facility doesn't carry the age 6 months to 4 years old Pfizer vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered outside of refrigeration window.  Thawed on 3/22.  Vaccine given 4/23.  No adverse event
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Liver disorder, Raynaud's phenomenon, Renal disorder, Seizure
Clinical narrative: Body convlused and fingers on right hand turned blue for more than two weeks. Doctor sent me to physical therapy. Other health problems inclde sudden growths on liver and kidney.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given an extra menveo dose. No adverse reactions as of 6:00pm when report was filed.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: There was no adverse reaction reported by patient.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Exfoliative rash, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: pt came back day after with raised, swollen, red rash on right forearm and right wrist.  both about 1-2 inches in length. it has a scaly/scabbed appearance (almost like a burn). states it started the morning after.  states it itches.  i advised to apply hydrocortisone cream as directed on otc packaging.  he works in the store, advised him to return if it gets worse or doesnt get better so we can reassess to determine if additional medical care is needed.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: pt came back day after with raised, swollen, red rash on right forearm and right wrist.  both about 1-2 inches in length. it has a scaly/scabbed appearance (almost like a burn). states it started the morning after.  states it itches.  i advised to apply hydrocortisone cream as directed on otc packaging.  he works in the store, advised him to return if it gets worse or doesnt get better so we can reassess to determine if additional medical care is needed.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: I have been healthy my entire life. No history of MS in my family. After receiving the vaccine, which I was REQUIRED to get as a condition of employment, I was diagnosed with multiple sclerosis. I didn't have MS before I got the vaccine. That's a fact. Against my desire, I was forced to get this vaccine because I didn't want to lose my job. I let a publicly traded company dictate what gets injected into my body and got the vaccine under duress. We were told the vaccine was a requirement of our job and anyone who didn't provide a vaccination card by a specific date would lose their job.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported.; patient who was administered an expired dose of ROTATEQ; This spontaneous report was received from a medical assistant and referred to a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 05-APR-2024 (also reported as "today"), the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose quantity reported as 2 milliliter (mL) administered orally in a three dose series for prophylaxis (strength was not reported; lot number 1912551 that was verified to be valid with an expiration date reported and established as 26-FEB-2024) (expired product administered).  It was confirmed that there were no reports of the patient involved experiencing any medical concerns or symptoms due to the administration of the expired dose; no additional adverse event or product quality complaint (PQC) were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Physician reported that an expired PROQUAD was administered to a patient; This spontaneous report was received from Physician referring to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 10-APR-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (rHA), lot #W024965, expiration date: 05-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided) that was expired. No additional adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE, no PQC; Caller requesting validity on a dose of MMRII that was administered today, 4/15/2024 but expired on 4/6/2024.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-APR-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) M-M-R II) injection, 0.5 (units not provided), lot #W028732, expiration date: 06-APR-2024 (strength, dose number and route of administration were not provided) administered for prophylaxis (Expired product administered). The caller requested validity on a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered. The reported confirmed that the vaccine had never undergone any temperature excursions. No additional adverse event, no product quality complaint PQC. No additional information.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Seizure
Clinical narrative: A 1-year-old experienced a seizure after receiving a dose of PROQUAD on 4/11/2024; This spontaneous report has been received from an office manager, concerning a 1-year-old male patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 11-APR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant human albumin) (PROQUAD) injection, one dose (lot number X018582 was verified to be valid, expiration date reported and confirmed as 05-JAN-2025), administered as prophylaxis (exact dose, route of administration, and anatomical location were not provided).  On the same day (11-APR-2024), after receiving the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD), the patient experienced a seizure.  The outcome of the event and its causal relationship with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD), were not reported. No additional information of the event, nor additional adverse event (AE) or product quality complaints (PQC) were provided.  Upon internal review, the event of seizure was determined to be medically significant.
Sex: M
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: First Dose Received Heplisav-B, One Month Later Received Engerix-B; Initial report received on 28-Mar-2024.  A pharmacist reported that a 62-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and was given ENGERIX-B as the second dose of a hepatitis B vaccine.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 26-Jan-2024, the patient received the first dose of a hepatitis B vaccine [HEPLISAV-B (lot # 943010, expiration date 31-Oct-2025, and NDC # 43528-003-05)] intramuscularly in the left deltoid from a pharmacist.   On 01-Mar-2024, the patient received the second dose of a hepatitis B vaccine [ENGERIX-B (lot #, expiration date, NDC #, route and site not provided)].  No adverse events were reported. No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Computerised tomogram, Exposure to chemical pollution, Fibromyalgia, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Manufacturer, and lot number unknown, anthrax shots, (2), were given during war. Symptoms I am currently experience are a numbness of the (L) scalp/face neck.  The symptoms started approximately two years after leaving the area of operation (AOR).  I am also experiencing a fibromyalgia of my (L) leg, this started just before retirement in 2003.  This may be due to toxic exposure of the burning oil well fires started and being downwind of the petrochemicals burning, and/or possible nerve agent exposure.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Occupational exposure to toxic agent
Clinical narrative: Manufacturer, and lot number unknown, anthrax shots, (2), were given during war. Symptoms I am currently experience are a numbness of the (L) scalp/face neck.  The symptoms started approximately two years after leaving the area of operation (AOR).  I am also experiencing a fibromyalgia of my (L) leg, this started just before retirement in 2003.  This may be due to toxic exposure of the burning oil well fires started and being downwind of the petrochemicals burning, and/or possible nerve agent exposure.
Age: 50.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Soreness at injection site, muscle aches, fever, fatigue
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Fall, Head injury, Loss of consciousness
Clinical narrative: Two times loss of consciousness causing to fall and hit head. Second time caused a seizure. Went to ER and two more seizures occurred there. Three seizures occurred total in the first 12 hours after vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Seizure
Clinical narrative: Two times loss of consciousness causing to fall and hit head. Second time caused a seizure. Went to ER and two more seizures occurred there. Three seizures occurred total in the first 12 hours after vaccination.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of product administration
Clinical narrative: Chills; received her first dose of Shingrix 26th January 2021 and did not receive her second dose until 3rd February 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 26th January 2021).   On 03-FEB-2024, the patient received the 2nd dose of Shingrix. On 03-FEB-2024, less than a day after receiving Shingrix, the patient experienced chills (Verbatim: Chills) and drug dose administration interval too long (Verbatim: received her first dose of Shingrix 26th January 2021 and did not receive her second dose until 3rd February 2024). The outcome of the chills was resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the chills to be related to Shingrix.   It was unknown if the company considered the chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2024 The patient did not receive her second dose until 3rd February 2024 and she had chills in the middle of the night, the night after receiving her second dose. The patient had no lot/expiry/route/location of administration for either dose of Shingrix. The patient did supplied the NDC from the paperwork from her second dose. The consent to follow up with healthcare professional was obtained, but the patient did not supply any healthcare professional information when asked. The patient received second dose of Shingrx later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Formication
Clinical narrative: crawling sensation under the skin; This non-serious case was reported by a consumer via call center representative and described the occurrence of crawling sensation in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (previous history of shingles in March 2023).   In JAN-2024, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm) .5 ml. On 31-MAR-2024, 3 months after receiving Shingrix, the patient experienced crawling sensation (Verbatim: crawling sensation under the skin). The outcome of the crawling sensation was not resolved.   It was unknown if the reporter considered the crawling sensation to be related to Shingrix.   It was unknown if the company considered the crawling sensation to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2024 The patient reported that she received her second Shingrix vaccine in January 2024 and the past week and a half she stated that it felt like something was crawling under her skin on her right upper back and left upper arm. The reporter reported it was not a constant crawling but came when she got anxious or nervous. The reporter was not sure if this crawling sensation was related to the Shingrix vaccine. The reporter would went to see her health care professional. The reporter given permission to contact her healthcare professional.
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: in the same day Pediarix and Engerix-B were administered to the same patient resulting in a double dose of hepatitis b; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 6-month-old female patient who received HBV (Engerix B) (batch number a32bb, expiry date 10-AUG-2025) and (batch number zp72s, expiry date 15-DEC-2024) for prophylaxis.   Previously administered products included Hepatitis b vaccine (dose received in 2023). Concomitant products included Pediarix.   On 08-APR-2024, the patient received Engerix B. On 08-APR-2024, an unknown time after receiving Engerix B, the patient experienced overdose (Verbatim: in the same day Pediarix and Engerix-B were administered to the same patient resulting in a double dose of hepatitis b). The outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-PR-2024 Medical assistant called to report that in the same day Pediarix and Engerix B were administered to the same patient resulting in a double dose of hepatitis-B vaccine, which led to overdose. The reporter consented to follow up. This is the patient 2 of 2 reported in the same phone call.; Sender's Comments:  US-GSK-US2024046333:Different patient
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Seizure
Clinical narrative: Patient received 1 dose of COVID vaccine and then 5 days later had a seizure but had 1 seizure in the past; Patient received 1 dose of COVID vaccine and then 5 days later had a seizure but had 1 seizure in the past; This is a spontaneous report received from a Pharmacist.  A 21-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Seizure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), DISEASE RECURRENCE (medically significant), all with latency 5 days after the suspect product(s) administration, outcome "recovered" and all described as "Patient received 1 dose of COVID vaccine and then 5 days later had a seizure but had 1 seizure in the past". It was unknown if therapeutic measures were taken as a result of seizure, disease recurrence. Clinical course: Patient received 1 dose of COVID vaccine and then 5 days later had a seizure (Patient not yet diagnosed with seizure disorder but had 1 seizure in the past). It was unknown if patient had COVID prior vaccination or had tested for COVID-19 post vaccination.; Sender's Comments: Based on the information available, known safety profile the causal association between the reported evets Seizure, Disease recurrence and suspect drug cannot be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Mom messaged via patient portal with concerns about a localized reaction. Patient's Left leg was red and warm to touch around injection site.
Sex: M
Vaccine: HEP
Symptoms: Enteral nutrition, Oxygen saturation decreased
Clinical narrative: patient was taking all feed by mouth after 2 days of life. patient was then given nirsevimab and hepatitis B vaccine on 12/16/2023 at 16:15 in anticipation of discharge. patient then started to have increased desaturation events and was subsequently required about a day of gavage feeding
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix (dtap/ polio) was given to patient at 18 months. kinrix is only approved for pts age 4-6 years old. No side effects were noted or mentioned. parents and provider notified.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pustule, Injection site warmth
Clinical narrative: Approximately 20 millimeters erythematous induration to the right upper posterior arm at the site of injection, with a one-millimeter pustule. Site warm to touch. Advised to monitor, wash site, and cover optional application of over-the-counter hydrocortisone cream. Seek medical attention in the event it does not resolve or worsens. Patients father denies symptoms other than pain at the site. Client alert and oriented and behavior is appropriate for age and no apparent sign of distress.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5, DTAPIPVHIB, PNC20, RV5
Symptoms: Crying, Enterovirus test, Human rhinovirus test, Respiratory pathogen panel
Clinical narrative: Unconsolably crying form 5pm to 11pm. Went to ER. No other causes found.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5, DTAPIPVHIB, PNC20, RV5
Symptoms: Chest X-ray, High-pitched crying, Human rhinovirus test positive, Immunisation reaction, Tremor
Clinical narrative: Unconsolably crying form 5pm to 11pm. Went to ER. No other causes found.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5, DTAPIPVHIB, PNC20, RV5
Symptoms: Viral test
Clinical narrative: Unconsolably crying form 5pm to 11pm. Went to ER. No other causes found.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5, DTAPIPVHIB, PNC20, RV5
Symptoms: Crying, Enterovirus test, Human rhinovirus test, Respiratory pathogen panel
Clinical narrative: Patient started to develop nasal congestion on Wednesday 4/10/24. I took him to the pediatrician the next day because this was the first time he'd ever been sick. He was evaluated and Dr. found nothing concerning in his ears, lung congestion, etc. Patient was eating and acting normal and never had a fever. We were recommended to keep suctioning his nose, run a humidifier, other supportive measures etc. On Monday 4/15/24 we went back to the pediatrician for his well visit and again, Dr. found nothing concerning on her assessment so we went forward with vaccination. His appointment was at 10:30 am. Throughout the day he acting normal but at about 5pm I gave him a weight appropriate dose of Tylenol (his first time having Tylenol) just as a preventative measure (I also thought maybe his gums were bothering him). He ate his normal formula around 6:30pm and at approximately 7:00pm he started to do a shrill scream cry that we had never heard before. He was fine one second and then starting doing this cry that was inconsistent with any cry he has done since birth. His mouth was partially closed, his hands were trembling and his chin was quivering. This went on for about 30 minutes after nothing we did helped, I called the pediatrician and we went to ER. He tested positive for Rhinovirus there and ER physician told us that he was likely experiencing an adverse reaction to the Pertussis component of Pentacel. The crying went on for between 2 and 2.5 hours until he finally fell asleep. When he woke up after sleeping for 2.5 hours he seemed to be back to his normal self.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5, DTAPIPVHIB, PNC20, RV5
Symptoms: Chest X-ray, High-pitched crying, Human rhinovirus test positive, Immunisation reaction, Tremor
Clinical narrative: Patient started to develop nasal congestion on Wednesday 4/10/24. I took him to the pediatrician the next day because this was the first time he'd ever been sick. He was evaluated and Dr. found nothing concerning in his ears, lung congestion, etc. Patient was eating and acting normal and never had a fever. We were recommended to keep suctioning his nose, run a humidifier, other supportive measures etc. On Monday 4/15/24 we went back to the pediatrician for his well visit and again, Dr. found nothing concerning on her assessment so we went forward with vaccination. His appointment was at 10:30 am. Throughout the day he acting normal but at about 5pm I gave him a weight appropriate dose of Tylenol (his first time having Tylenol) just as a preventative measure (I also thought maybe his gums were bothering him). He ate his normal formula around 6:30pm and at approximately 7:00pm he started to do a shrill scream cry that we had never heard before. He was fine one second and then starting doing this cry that was inconsistent with any cry he has done since birth. His mouth was partially closed, his hands were trembling and his chin was quivering. This went on for about 30 minutes after nothing we did helped, I called the pediatrician and we went to ER. He tested positive for Rhinovirus there and ER physician told us that he was likely experiencing an adverse reaction to the Pertussis component of Pentacel. The crying went on for between 2 and 2.5 hours until he finally fell asleep. When he woke up after sleeping for 2.5 hours he seemed to be back to his normal self.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5, DTAPIPVHIB, PNC20, RV5
Symptoms: Viral test
Clinical narrative: Patient started to develop nasal congestion on Wednesday 4/10/24. I took him to the pediatrician the next day because this was the first time he'd ever been sick. He was evaluated and Dr. found nothing concerning in his ears, lung congestion, etc. Patient was eating and acting normal and never had a fever. We were recommended to keep suctioning his nose, run a humidifier, other supportive measures etc. On Monday 4/15/24 we went back to the pediatrician for his well visit and again, Dr. found nothing concerning on her assessment so we went forward with vaccination. His appointment was at 10:30 am. Throughout the day he acting normal but at about 5pm I gave him a weight appropriate dose of Tylenol (his first time having Tylenol) just as a preventative measure (I also thought maybe his gums were bothering him). He ate his normal formula around 6:30pm and at approximately 7:00pm he started to do a shrill scream cry that we had never heard before. He was fine one second and then starting doing this cry that was inconsistent with any cry he has done since birth. His mouth was partially closed, his hands were trembling and his chin was quivering. This went on for about 30 minutes after nothing we did helped, I called the pediatrician and we went to ER. He tested positive for Rhinovirus there and ER physician told us that he was likely experiencing an adverse reaction to the Pertussis component of Pentacel. The crying went on for between 2 and 2.5 hours until he finally fell asleep. When he woke up after sleeping for 2.5 hours he seemed to be back to his normal self.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Fatigue, Gait disturbance, Myalgia, Pain
Clinical narrative: Sore muscles and fatigue, aches and pains.  +Fevers, difficulty walking
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Sore muscles and fatigue, aches and pains.  +Fevers, difficulty walking
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Once home within 1 hour mild anxiety and uneasiness.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Multiple organ dysfunction syndrome
Clinical narrative: Multi organ system failure leading to death
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Client received Tdap and MenACWY vaccine outside of recommended schedule.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Computerised tomogram, Echocardiogram, Electrocardiogram abnormal, Extrasystoles
Clinical narrative: started with skipped beats in my heart and then turned to A-fib which i still have.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cytogenetic analysis, Ear discomfort, Electrocardiogram, Feeling abnormal
Clinical narrative: Begin to have some anxiety after the vaccine. My eyes becoming the very hypersensitive to all lights. I began to have feelings of alter mental status. unable to recall my PIN number to my ATM debit card unable to pay my rent all the sudden I just became very forgetfulness. I began to have ringing in the ears like a metal Sensations like a drill bit was Drilling in my ear I begin to help swishing sounds sounds like air being let out of a tire also sounds like tuning Forks in both of my ears sounds like something was trying to take over my my eardrum, metal sounds. I began to think someone was coming in my apartment people was following me Etc. I begin to tell family that something was wrong something that's not right I have never felt like this year before I'm going to the emergency room to see if I can get treatment and figure out what's happening. I was calling the local police for help as well.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Loss of personal independence in daily activities, Magnetic resonance imaging, Memory impairment, Mental status changes
Clinical narrative: Begin to have some anxiety after the vaccine. My eyes becoming the very hypersensitive to all lights. I began to have feelings of alter mental status. unable to recall my PIN number to my ATM debit card unable to pay my rent all the sudden I just became very forgetfulness. I began to have ringing in the ears like a metal Sensations like a drill bit was Drilling in my ear I begin to help swishing sounds sounds like air being let out of a tire also sounds like tuning Forks in both of my ears sounds like something was trying to take over my my eardrum, metal sounds. I began to think someone was coming in my apartment people was following me Etc. I begin to tell family that something was wrong something that's not right I have never felt like this year before I'm going to the emergency room to see if I can get treatment and figure out what's happening. I was calling the local police for help as well.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Photophobia, Tinnitus
Clinical narrative: Begin to have some anxiety after the vaccine. My eyes becoming the very hypersensitive to all lights. I began to have feelings of alter mental status. unable to recall my PIN number to my ATM debit card unable to pay my rent all the sudden I just became very forgetfulness. I began to have ringing in the ears like a metal Sensations like a drill bit was Drilling in my ear I begin to help swishing sounds sounds like air being let out of a tire also sounds like tuning Forks in both of my ears sounds like something was trying to take over my my eardrum, metal sounds. I began to think someone was coming in my apartment people was following me Etc. I begin to tell family that something was wrong something that's not right I have never felt like this year before I'm going to the emergency room to see if I can get treatment and figure out what's happening. I was calling the local police for help as well.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Allergy to vaccine, Anxiety, Immediate post-injection reaction, Throat irritation, Urticaria
Clinical narrative: Patient exhibited increased anxiety right after receiving the HPV vaccine, was observed in the office by provider for about an hour after the injection. No medication administered at that time.  Mother brought patient to ER later that evening after patient complained of scratchy throat and some hives. Mother gave patient Benadryl at 6:15 PM and Epipen Jr at 7:15 PM prior to arrival at ER. Patient was evaluated by ER provider at 8:40 PM. At that time patient reported feeling better, throat scratchiness gone.  Patient was given  oral prednisone in ER at 8:42 PM and observed until discharge at 10:53 PM.   HPV vaccine was added to patient's allergy profile by PCP.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event
Clinical narrative: No adverse event
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose was given verses the pediatric dose.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site induration, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: Large hard nodules on left deltoid with itching. Cortisol cream applied, area warm to touch. Denies fever or Shortness of breath.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site bruising, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: pt received this 3rd dose at pharmacy on 4/09/2024.  She called our office on 4/12/2024 to let us know she received the vaccine - patient also made appointment with us on this day due to left arm pain where shot was administered.  When our staffed went to enter this vaccine in our records - we found that she had already received 2 prior doses at our office.  1st dose: 8/10/2020 and 2nd dose: 10/12/2020.  Nothing noted that I can see that she had an issue with either of these doses. Providers note from DOS: 4-12-2024 states: Left Shoulder: Over the midportion of the deltoid there is a fairly well-demarcated area of erythema with increased warmth.  the area is approximately 3 inches x 4 inches in size.  There is a purplish bruise at the apex of the affected area. Significant tenderness to palpation over the 1 inch bruise.  No Fluctuance. Mild induration.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: pt received this 3rd dose at pharmacy on 4/09/2024.  She called our office on 4/12/2024 to let us know she received the vaccine - patient also made appointment with us on this day due to left arm pain where shot was administered.  When our staffed went to enter this vaccine in our records - we found that she had already received 2 prior doses at our office.  1st dose: 8/10/2020 and 2nd dose: 10/12/2020.  Nothing noted that I can see that she had an issue with either of these doses. Providers note from DOS: 4-12-2024 states: Left Shoulder: Over the midportion of the deltoid there is a fairly well-demarcated area of erythema with increased warmth.  the area is approximately 3 inches x 4 inches in size.  There is a purplish bruise at the apex of the affected area. Significant tenderness to palpation over the 1 inch bruise.  No Fluctuance. Mild induration.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Chest X-ray normal, Fatigue, Headache, Lymphadenopathy, Oedema peripheral
Clinical narrative: right armpit swelling/adenopathy, headache, fatigue, "shakiness"
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: right armpit swelling/adenopathy, headache, fatigue, "shakiness"
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Migraine, Pain, Paraesthesia, Paraesthesia oral
Clinical narrative: Woke feeling "achy" the day after vaccination. After going for a hike in the morning, developed headache, tingling in left arm, face and tongue, with vision changes in the afternoon. Described as "migraine." Reported symptoms improving in the late afternoon.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Visual impairment
Clinical narrative: Woke feeling "achy" the day after vaccination. After going for a hike in the morning, developed headache, tingling in left arm, face and tongue, with vision changes in the afternoon. Described as "migraine." Reported symptoms improving in the late afternoon.
Age: 81.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Rash
Clinical narrative: After 5 1/2 months, it still itches and is red at the site. It still itches, especially when I take a shower. I says on the internet that it can have an ae like rash or hives, and that's kinda what I have on my body. That started like 3-3 weeks now on my body.  I've been using over the counter Cortisone 10. I am going to see a dermatologist. I thought Pfizer could help me, but they cant.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired. No adverse effects noted.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Doctor order a Hep B vaccine for a 19 year old male. When I opened up patient's chart to give vaccine, I saw Hep B vaccine but not that it was a ped vaccine. I got Hep B for adult. I got Hep B vaccine from vaccine fridge. I had Dr. verified the Hep B vaccine. When entering the room, I vetified patient's date of birth and full name. I give patient his vaccine. When I was done with the patient, I documented the vaccine in patient's chart but when I tried to put in the LOT number but nothing came up. In that moment I noted Dr. order a ped Hep B and not an adult Hep B. Dr.  cancelled Hep B ped vaccine and order an adult Hep B vaccine.
Age: 8.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Blood cholesterol, Loss of consciousness, Syncope
Clinical narrative: Pt received Menquadfi vaccine then immediately following had her finger stuck for a capillary cholesterol test. Specimen obtained then pt proceeded to have syncope episode. Pt was layed down on exam table with no injury and immediately regained consciousness.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: PATIENT EXPERIENCED "ZINGER" NERVE-TYPE PAIN IN HER NECK, TOES, AND OTHER RANDOM PLACES OVER HER BODY ABOUT 48 HOURS AFTER GETTING FIRST DOSE OF SHINGRIX
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Fatigue, Nasopharyngitis
Clinical narrative: When patient came back into pharmacy 24 days after the administration of the vaccine, she reported feeling dizzy after the vaccine and being very tired and felt like she "had a cold" for approximately 7 days after the vaccine.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Atrial flutter, Electrocardiogram, Heart rate irregular
Clinical narrative: atrial flutter, rapid ventricular response, fluctuating heart beat,
Age: 1.08
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Varicella vaccine given twice in error. MMRV was not supposed to be administered by nurse. MMR was supposed to be the intended vaccine. This error was found today due to reconciliation of vaccines through system.  The parent has not called to report any side effects at this time.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Hepatitis A vaccine, 2nd dose, was administered 5 days shy of the 6 month window between doses. No reported symptoms by patient. Guardian informed that a 3rd dose should be administered 6 months from april 22 (10/22/24) at the earliest. Guardian verified understanding.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was BUD
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Injection site abscess sterile
Clinical narrative: 2.5 x 1.0 cm sterile abscess in right thigh at site of Vaxelis injection.  Child has received all components of this vaccine previously but as Pentacel  plus Hepatitis B
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered 1 day after expiration date.  no adverse symptoms
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Wrong product administered
Clinical narrative: Possibility that patient received HPV vaccine instead of PCV20 due to documentation correlating to HPV vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered 1 day after expiration, no adverse reaction, no symptoms
Age: 23.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: 23 year old pregnant patient was given arexvy instead of abrysvo. patient is 36 weeks pregnant
Age: 23.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: 23 year old pregnant patient was given arexvy instead of abrysvo. patient is 36 weeks pregnant
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: swollen red hot to touch area of injection site
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Wrong product administered
Clinical narrative: Patient likely received HPV vaccine instead of PCV vaccine as noted in documentation- incorrect lot number .
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Laboratory test
Clinical narrative: Stroke
Age: 34.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: Patient has history of MPox infection in 2022. Patient requested to be vaccinated due to high risk MSM behavior. Vaccine administered. Patient tolerated vaccine without difficulty.
Age: 17.0
Sex: F
Vaccine: MNQ, SMALL
Symptoms: Vaccination site cellulitis, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: On 4/21 began to have erythema, swelling and pain in area of vaccination- Left upper lateral arm, that worsened over the 24 hours to 4/22/24. Seen by medical provider on 4/22, diagnosed with cellulitis and prescribed Septra. Started Septra, seen on 4/23 to follow-up with provider, and cellulitis had started to resolve.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC20
Symptoms: Wrong product administered
Clinical narrative: Patient likely received HPV vaccine instead of PCV20 vaccine as noted in vaccine documentation.
Age: 64.0
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given MMR vaccine too soon. Should be given 28 days apart, was given 23 days from first dose.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine BUD - no other symptoms
Age: 14.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Dizziness, Nausea, Retching
Clinical narrative: Pt received  3 vaccinations. MMR, Varicella, and Hepatitis A. After administering vaccinations, RN had Pt sit in chair. Pt placed head in lap. RN assessed if Pt was feeling well. Pt stated she was fine and just wanted to place her head down. Pt excused herself accompanied by mother to restroom. RN asked if everything was ok patient and mother assured everything was fine. Supervisor walked down hallway and heard Pt retching and asked mother if Pt was just vaccinated. Mother replied yes. Vitals done immediately after. Water was given to Pt. Pt's mother stated she ate breakfast but did not receive lunch. Pt stated to supervisor that she felt nauseous and  faint in room after receiving last vaccine but was feeling much better after vomiting. Pt VS WNL after incident in bathroom.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse events occurred per patient Mother.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received pediatric dosage
Age: 61.0
Sex: M
Vaccine: RSV
Symptoms: Injection site pain, Product preparation error
Clinical narrative: Patient was given the sterile water only. Pharmacist noticed the error and then with patient's permission the actual vaccine was then given. Patient experienced no adverse effects from the sterile water except injection site pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Swelling in armpit two days after vaccine was administered, no fever or any other symptom
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Back pain, Headache, Meningococcal infection, Nausea, Neck pain
Clinical narrative: She received meningococcal vaccine MenB dose#1 and Men ACWY dose #2 on 4/3/24, approx 2 weeks before symptom onset.   Diagnosed with meningococcal disease on 4/15/24. Symptom onset 4/14/24 of nausea, vomiting, headaches, back/neck pain, but no fever.  She was treated with ceftriaxone.