chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Parkinson's disease, Sleep disorder, Tremor, Vibratory sense increased, X-ray
Clinical narrative: Almost immediately, next day, had severe throbbing and injection site pain.   I spoke to a nurse shortly after the vaccine injection and her opinion was that  it likely would resolve.  However, the pain continued for several weeks, and then I developed a small  tingling (neuropathy) in my hands and feet that was severe enough at night to wake me from sleep.  This continued for several months and then it slowly transitioned over time from a tingling to a sensation of an internal vibration, and then over the next couple months it turned into a tremor in my left arm and hand.  Around January 2022, I began having a toe/foot cramping periodically (maybe once every few weeks)  By April 2022, the daily tremor had not resolved, and the foot cramping became more frequent (weekly/daily),  and the symptoms were bothersome and consistent enough that I mentioned it to my practitioner.    This since led me to have orthopedic and neurology evaluations, and around September 2022 the neurologist diagnosed me with Early Onset Parkinson's disease.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9, MNQ, MNQ, TDAP, TDAP
Symptoms: Syncope
Clinical narrative: Patient had syncopal event less than 15 minutes following routine administration of Tdap, Men ACWY, and HPV vaccine. Patient quickly recovered and assisted to sitting position, HR 90s, Respirations easy and unlabored. Patient provided with juice, and after slowly standing up, patient states she is feeling better and demonstrates walking a few steps without difficulty.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Scratch, Syncope
Clinical narrative: Patient fainted for about 10 seconds and scraped the right side of the head against the wall. The nurse provided care by tapping on his chest and calling his name. He responded and was oriented to person, place, time, and situation.  We provided a cold pack to apply to the head and monitored the patient for about 30 minutes while he remained sitting on the floor conscious. He took some sips of water and stood up to seat in the chair stating feeling well.  We asked the parent if they want it us to call the paramedics for a further evaluation and they declined. Patient left the mobile unit walking accompanied by parent. The patient and the parent were advised to seek medical attention if experiencing any abnormal sign or symptom such as headache, fainting, nausea and/or vomiting, blurred vision, dizziness. The parent was asked again before they left if they wanted paramedics to evaluate the patient and they declined again.
Age: 66.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Pain, Pyrexia, Rash, Skin warm
Clinical narrative: Patient presents at pharmacy on 07/11/2024 per physician recommendation, Per patient  , reaction started midnight on 07/09/2024 with soreness pain, fever. Today, 07/11/2024 she noticed rash warm to touch so called physician, Pt was consulted to monitor rash to make sure not spreading or getting worse. Use ice treatment and may take OTC Tylenol for soreness. Also refer to physician,
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Unevaluable event
Clinical narrative: DUE TO HAVING  I MISSED WORK DUE TO TAKING STRONG MEDICATION THAT MAKE YOU SLEEPY AND VERY TRIED SO I HAD TO WORK HALF DAYS.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Fever-Severe, Systemic: Headache-Medium, Systemic: Tachycardia-Severe, Additional Details: patient went to er for cellulitis at the site of injection.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Fever-Severe, Systemic: Headache-Medium, Systemic: Tachycardia-Severe, Additional Details: patient went to er for cellulitis at the site of injection.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Asthenia, Autoimmune disorder, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Mild, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient reported fever that lasted one day after receiving the vaccine. Then patient experienced numbness in legs and arms and joint pain. When patient saw her PCP, PCP directed her to go to the ER for suspected Guillain-Barre. Employee at PCP informed the pharmacy. Patient reported to pharmacy she was in the hospital for 9 days and diagnosed with an auto-immune disease/ambulatory dysfunction. Patient continues to have numbness/weakness in legs and has follow-up with her PCP and neurology.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia, Injection site pain, Muscular weakness, Pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Mild, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient reported fever that lasted one day after receiving the vaccine. Then patient experienced numbness in legs and arms and joint pain. When patient saw her PCP, PCP directed her to go to the ER for suspected Guillain-Barre. Employee at PCP informed the pharmacy. Patient reported to pharmacy she was in the hospital for 9 days and diagnosed with an auto-immune disease/ambulatory dysfunction. Patient continues to have numbness/weakness in legs and has follow-up with her PCP and neurology.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: swelling and redness "like a tomato"-Medium
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: swelling and redness "like a tomato"-Medium
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: Site: Bruising at Injection Site-Mild, Additional Details: patient came in 07/03/24- reported post vaccine bruising and darker skin discoloration and pigmentation in area of vaccine right arm, no pain, no swelling, no itching, no other issues, no signs of infection just darker skin about cm in area of vaccination
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt came to receive the moderna covid booster and Tdap Boostrix vaccine. After receiving the covid vaccine first and while just finished adminstering the tdap vaccine, right after retracting the needle from pt's arm, pt started to feel unconscious and pt was helped to lay on the floor and 911 was called. Pt regained consciousness in a few seconds and was sitting upright. pt was offered water. EMT checked pt and pts BP was low. Pt went home after being evaluated and messaged to reach home safely. , Other Vaccines:  VaccineTypeBrand: BOOSTRIX; Manufacturer: GSK; LotNumber: 333BM; Route: IM; BodySite: RIGHT ARM; Dose: 1; VaxDate: 07/06/2024
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Fall, Flushing, Nausea, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: nausea, syncope-Mild, Additional Details: Td vaccine administered to patient, patient waited in the lobby for 15 minutes after vaccine was administered. Then she left. As staff was leaving the clinic, met with patient been held by her son and husband, they stated patient fell. Patient appeared flushed, c/o feeling nauseous, assisted patient to bed. Vital signs taken bp 90/57. HR 55. Called EMS who came and evaluated patient and later sent patient to the ER for further evaluation.
Age: 63.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: LEFT ARM VARICELLA INJECTION SITE WITH RED INDURATED AREA APPROX. 1.5 X 3 INCHES. WARM TO TOUCH C/O PAIN WHEN TOUCHED
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: see page 1 with details on onset of event, treatment received and disposition
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Immunisation
Clinical narrative: The patient had hepatitis B surface antibodies tested and was nonreactive and didn't have immunity from prior hepatitis B vaccinations. Based on information from the Foundation - CDC Recommendations section for Hepatitis B vaccine non - responders, a second series using a different brand of vaccine should be administered. Provider ordered Heplisav-B 2 - dose series to ensure patient was covered for her trip to another country.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, MENB, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: TRUMENBA ADMI NISTERED IN ERROR- NO KNOWN ADVERSE REACTIONS AT THIS TIME
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The vaccine administered was expired. The date on the vaccine is 7-8-2024. The day the vaccine was administered was 7-10-2024. No adverse reaction occurred.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Dermatitis, Full blood count normal, Injection site reaction, Metabolic function test
Clinical narrative: Erythematous papules to left chest and left posterior upper arm appeared one week after vaccine injection. Biopsy revealed interface dermatitis, possibly drug eruption.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Papule
Clinical narrative: Erythematous papules to left chest and left posterior upper arm appeared one week after vaccine injection. Biopsy revealed interface dermatitis, possibly drug eruption.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Laboratory test, Magnetic resonance imaging, X-ray limb
Clinical narrative: Localized pain and swelling at injection site, pain continued in intensity over the week after vaccine. Employee had follow up visit with occupational health after event.
Age: 65.0
Sex: F
Vaccine: MMR
Symptoms: Dysarthria
Clinical narrative: Patient's caregiver called clinic after leaving, stated patient "could not talk" and was slurring her speech. Was advised by RN to go to emergency room.
Sex: U
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable and we had to revaccinate the patients.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Eye movement disorder, Glassy eyes, Loss of consciousness, Nausea
Clinical narrative: Patient stated feels like may pass out. Patient to remain sitting and water offered and along with a piece of candy as patient was looking pale. Patient accepted. Patient then slumped down in chair onto right side with RN present and within few seconds came back and asked how long was out for and let her know. She then verbalized needing to throw up and bucket was given. Patient slumped over in chair again but with legs extended straight out with arms up tight and eye rolling and after came to with glazed look asking what is going on. Patient was take to ER for evaluation.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Pallor, Posture abnormal
Clinical narrative: Patient stated feels like may pass out. Patient to remain sitting and water offered and along with a piece of candy as patient was looking pale. Patient accepted. Patient then slumped down in chair onto right side with RN present and within few seconds came back and asked how long was out for and let her know. She then verbalized needing to throw up and bucket was given. Patient slumped over in chair again but with legs extended straight out with arms up tight and eye rolling and after came to with glazed look asking what is going on. Patient was take to ER for evaluation.
Age: 84.0
Sex: M
Vaccine: COVID19-2, RSV
Symptoms: Hypoaesthesia, Laboratory test, Pain in extremity
Clinical narrative: pain in right arm, numbness in right 2 fingers. pinky and ring finger
Age: 68.0
Sex: M
Vaccine: TD
Symptoms: Incorrect dose administered
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 74.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was administered an expired vaccine. Pt did not have any adverse reactions.
Age: 9.0
Sex: M
Vaccine: PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PCV20 GIVEN, PATIENT AGED OUT OF VACCINE
Age: 6.0
Sex: M
Vaccine: PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PCV20 GIVEN TO PATIENT WHO HAS AGED OUT OF VACCINE, FAMILY WAS NOTIFIED.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 17.0
Sex: M
Vaccine: UNK
Symptoms: Full blood count, Mononucleosis heterophile test positive, Oropharyngeal pain, Pharyngeal erythema, Rash
Clinical narrative: Rash over abdomen, chest, arms, groin, legs. Red sore throat . Rash has not resolved,
Age: 17.0
Sex: M
Vaccine: UNK
Symptoms: Streptococcus test negative
Clinical narrative: Rash over abdomen, chest, arms, groin, legs. Red sore throat . Rash has not resolved,
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 52.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 36.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Per patient's neurologist office, patient developed Guillain-Barre syndrome. Treatment is unknown.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Brain compression, Budd-Chiari syndrome, Computerised tomogram, Death
Clinical narrative: Hospital MRN: DOB:  Sex: F Adm: 11/29/2021, D/C: 12/1/2021 11/29/2021 - ED to Hosp-Admission (Discharged) in Hospital Critical Care (continued) Final Diagnoses (ICD-10-CM) Code Description POA CC HAC Affects DRG I82.0 [Principal] Budd-Chiari syndrome (HCC) Yes No Yes G93.5 Compression of brain (HCC) Yes MCC Yes Z66 Do not resuscitate No No No G93.82 Brain death No MCC No G93.6 Cerebral edema (HCC) Yes MCC No J96.01 Acute respiratory failure with hypoxia (HCC) Yes MCC No R40.20 Unspecified coma (HCC) Yes MCC No I47.2 Ventricular tachycardia (HCC) Yes CC No G93.40 Encephalopathy, unspecified Yes CC No I51.81 Takotsubo syndrome Yes CC No N39.0 Urinary tract infection, site not specified Yes CC No E87.2 Acidosis Yes CC No E87.0 Hyperosmolality and hypernatremia Yes CC No G93.1 Anoxic brain damage, not elsewhere classified (HCC) No CC No E23.2 Diabetes insipidus (HCC) Yes CC No B08.3 Erythema infectiosum (fifth disease) Yes CC No I46.2 Cardiac arrest due to underlying cardiac condition (HCC) Yes No No G40.901 Epilepsy, unspecified, not intractable, with status epilepticus (HCC) Yes No No L27.0 Generalized skin eruption due to drugs and medicaments taken internally Yes No No T36.8X5A Adverse effect of other systemic antibiotics, initial encounter Yes No No G44.53 Primary thunderclap headache Yes No No K76.0 Fatty (change of) liver, not elsewhere classified Yes No No Z20.822 Contact with and (suspected) exposure to covid-19 Yes No No D69.6 Thrombocytopenia, unspecified (HCC) Yes No No R74.01 Elevation of levels of liver transaminase levels Yes No No R19.7 Diarrhea, unspecified Yes No No R11.10 Vomiting, unspecified Yes No No R23.1 Pallor Yes No No Z86.16 Personal history of COVID-19 Exempt from POA reportin g No No Visit Information Admission Information Arrival Date/Time: 11/29/2021 0812 Admit Date/Time: 11/29/2021 0847 IP Adm. Date/Time: 11/29/2021 1500 Admission Type: Emergency Point of Origin: Home Admit Category: Means of Arrival: Walk In Primary Service: Medicine Secondary Service: N/A Transfer Source: Service Area:  SERVICE AREA Unit:  Hospital  Critical Care Admit Provider:   DO Attending Provider: MD Referring Provider: Discharge Information Discharge Date/Time Discharge Disposition Discharge Destination Discharge Provider Unit 12/01/2021 1315 *Expired Acute Care Hospital Other MD Hospital Critical Care Printed by at 3/4/22 10:18 AM Page
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Magnetic resonance imaging
Clinical narrative: Hospital MRN: DOB:  Sex: F Adm: 11/29/2021, D/C: 12/1/2021 11/29/2021 - ED to Hosp-Admission (Discharged) in Hospital Critical Care (continued) Final Diagnoses (ICD-10-CM) Code Description POA CC HAC Affects DRG I82.0 [Principal] Budd-Chiari syndrome (HCC) Yes No Yes G93.5 Compression of brain (HCC) Yes MCC Yes Z66 Do not resuscitate No No No G93.82 Brain death No MCC No G93.6 Cerebral edema (HCC) Yes MCC No J96.01 Acute respiratory failure with hypoxia (HCC) Yes MCC No R40.20 Unspecified coma (HCC) Yes MCC No I47.2 Ventricular tachycardia (HCC) Yes CC No G93.40 Encephalopathy, unspecified Yes CC No I51.81 Takotsubo syndrome Yes CC No N39.0 Urinary tract infection, site not specified Yes CC No E87.2 Acidosis Yes CC No E87.0 Hyperosmolality and hypernatremia Yes CC No G93.1 Anoxic brain damage, not elsewhere classified (HCC) No CC No E23.2 Diabetes insipidus (HCC) Yes CC No B08.3 Erythema infectiosum (fifth disease) Yes CC No I46.2 Cardiac arrest due to underlying cardiac condition (HCC) Yes No No G40.901 Epilepsy, unspecified, not intractable, with status epilepticus (HCC) Yes No No L27.0 Generalized skin eruption due to drugs and medicaments taken internally Yes No No T36.8X5A Adverse effect of other systemic antibiotics, initial encounter Yes No No G44.53 Primary thunderclap headache Yes No No K76.0 Fatty (change of) liver, not elsewhere classified Yes No No Z20.822 Contact with and (suspected) exposure to covid-19 Yes No No D69.6 Thrombocytopenia, unspecified (HCC) Yes No No R74.01 Elevation of levels of liver transaminase levels Yes No No R19.7 Diarrhea, unspecified Yes No No R11.10 Vomiting, unspecified Yes No No R23.1 Pallor Yes No No Z86.16 Personal history of COVID-19 Exempt from POA reportin g No No Visit Information Admission Information Arrival Date/Time: 11/29/2021 0812 Admit Date/Time: 11/29/2021 0847 IP Adm. Date/Time: 11/29/2021 1500 Admission Type: Emergency Point of Origin: Home Admit Category: Means of Arrival: Walk In Primary Service: Medicine Secondary Service: N/A Transfer Source: Service Area:  SERVICE AREA Unit:  Hospital  Critical Care Admit Provider:   DO Attending Provider: MD Referring Provider: Discharge Information Discharge Date/Time Discharge Disposition Discharge Destination Discharge Provider Unit 12/01/2021 1315 *Expired Acute Care Hospital Other MD Hospital Critical Care Printed by at 3/4/22 10:18 AM Page
Age: 30.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Muscular weakness, Myalgia, Sleep disorder
Clinical narrative: 3 days after vaccination in the middle of the night the patient woke with severe muscle pain. The pain has continued thru 07/11/2024 at the time of this report. Patient is also reporting muscle weakness in the arm.
Age: 70.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood glucose, Decreased appetite, Dehydration, Diarrhoea, Differential white blood cell count
Clinical narrative: Baby developed looser stools that were greenish and then some with blood on 7/5/24.  Appetite dropped over the next day and she became dehydrated prompting ER visit and subsequent hospitalization from 7/7/24 through 7/8/2024
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Faeces discoloured, Full blood count, Haematochezia, Metabolic function test
Clinical narrative: Baby developed looser stools that were greenish and then some with blood on 7/5/24.  Appetite dropped over the next day and she became dehydrated prompting ER visit and subsequent hospitalization from 7/7/24 through 7/8/2024
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: CAME IN WEDNESDAY NIGHT LEFT ARM RED SWOLLEN ITCHY I SUGGESTED TYLENOL ICE AND BENADRYL AND MARK THE MARGINS THURSDAY REDNESS HAS NOT EXPANDED SWELLING IS NOT GREATER
Age: 94.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Dose was given without the powder mixture, only received the liquid portion of the vaccine, no reaction was noted.
Age: 71.0
Sex: M
Vaccine: HEPAB
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: PATIENT IS EXPERIENCING NAUSEA, VOMITING, AND DIARHEA.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Rash vesicular, Swelling
Clinical narrative: Swelling, shingles-like rash, discomfort for seven days
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given spoiled vaccine that was involved in a temperature excursion. Patient tolerated vaccine well and did not develop any adverse reactions.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 87.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient was given spoiled vaccine that was involved in a temperature excursion. Patient tolerated the vaccine well and did not develop any adverse reactions.  Patient is currently at Academy. Medical Director at Academy was informed of incident by Practice Manager and Board Director.
Age: 70.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 59.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 0.58
Sex: M
Vaccine: HIBV, UNK
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Patient was administered the incorrect vaccine by the medical assistant in his pediatrician's office. He was given a 4th dose of PCV15 when he was supposed to be receiving just the D-tap vaccine from the Pediatric combo vaccine. This error was made by the medical assistant under Dr.'s sign off.
Age: 75.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood test normal, Bradykinesia, Computerised tomogram head normal, Dizziness
Clinical narrative: Began as numbness in left arm pinky side from elbow down to pinky finger around 8AM, abruptly progressed to pain in calf muscles, tachycardia, developed bilateral myasthenia and bradykinesia in all appendages from shoulder and hip down , accompanied by dizziness and fatigue beginning around 8:45AM. Most symptoms subsided by 11AM except for bilateral myasthenia, bradykinesia and fatigue. Symptoms lasted the rest of the night. From the next morning on, I am still experiencing slight motor delay and slight myasthenia along with occasional myoclonus.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Fatigue, Heart rate increased, Hypoaesthesia, Muscular weakness
Clinical narrative: Began as numbness in left arm pinky side from elbow down to pinky finger around 8AM, abruptly progressed to pain in calf muscles, tachycardia, developed bilateral myasthenia and bradykinesia in all appendages from shoulder and hip down , accompanied by dizziness and fatigue beginning around 8:45AM. Most symptoms subsided by 11AM except for bilateral myasthenia, bradykinesia and fatigue. Symptoms lasted the rest of the night. From the next morning on, I am still experiencing slight motor delay and slight myasthenia along with occasional myoclonus.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Myoclonus, Pain in extremity, Urine analysis normal
Clinical narrative: Began as numbness in left arm pinky side from elbow down to pinky finger around 8AM, abruptly progressed to pain in calf muscles, tachycardia, developed bilateral myasthenia and bradykinesia in all appendages from shoulder and hip down , accompanied by dizziness and fatigue beginning around 8:45AM. Most symptoms subsided by 11AM except for bilateral myasthenia, bradykinesia and fatigue. Symptoms lasted the rest of the night. From the next morning on, I am still experiencing slight motor delay and slight myasthenia along with occasional myoclonus.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Patient given spoiled vaccine that was involved in a temp excursion. Patient tolerated vaccine well and did not develop any adverse reactions. Patient is currently at Academy. The Medical Director at Academy was informed of the incident by our Practice Manager and Board Director.
Age: 37.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 80.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Swelling and redness to vaccination site
Age: 28.0
Sex: M
Vaccine: TD
Symptoms: Impaired work ability
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient given spoiled vaccine that was involved in temp excursion. Patient tolerated vaccine well and did not develop any adverse reactions. Patient is currently residing at facility. Their Medical Director has been informed of incident by our Practice Manager and Pediatric Board Director.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray, Lethargy, Limb mass, Malaise, Pulmonary oedema
Clinical narrative: Lethargic, fever, felt sick, lump on arm, water on lungs
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Lethargic, fever, felt sick, lump on arm, water on lungs
Age: 78.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 8.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccination given to child over 6 years of age. No immediate adverse effects noted, all vital signs within normal limits.
Age: 40.0
Sex: M
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 71.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 11.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pediarix vaccine administered to child older than 6 years. No immediate adverse effects noted. All vital signs within normal limits
Age: 10.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccination given to child over 6 years of age. No immediate adverse effects noted, all vital signs within normal limits.
Age: 7.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccination given to child over 6 years of age. No immediate adverse effects noted, all vital signs within normal limits.
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Throat irritation, Urticaria
Clinical narrative: Intermittent hives systemicly ongoing, temporary relief with OTC treatment with recurring episodes worsening over three weeks.
Age: 8.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pediarix vaccination given to child over 6 years of age. No immediate adverse effects noted, all vital signs within normal limits.                                    MMRV proquad vaccination given to child after already receiving two doses of varicella vaccine, should have only been given MMR. No immediate adverse effects noted, all vital signs within normal limits.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Decreased appetite, Fatigue, Headache, Nodule, Pain in extremity
Clinical narrative: Severe headache, fatigue, no appetite, sore arm/knot, vomiting - bile
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Vomiting
Clinical narrative: Severe headache, fatigue, no appetite, sore arm/knot, vomiting - bile
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Caller reported vaccines were administered after temperature excursions.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 03-JUN-2024 the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # X023403 and expiration date 03-APR-2025 for prophylaxis (exact dose, dose number and route of administration were not provided). The excursion lasted for 58 minutes in temperature of 48.4 Fahrenheit degrees (F). No additional adverse events or product quality complaints were reported (product storage error and no adverse event).     ; Sender's Comments:  US-009507513-2406USA004946:
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Irritability, Rash
Clinical narrative: began to break out into a rash that covered most of his body; My son has been fussy and it is difficult to judge how he is doing; He also has a loss of appetite; This spontaneous report was received from the patient's mother and refers to a 1-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-MAY-2024, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter (of two dose series), administered intramuscularly for measles, mumps, rubella prevention (strength, lot #, expiration date, albumin status were not provided).  On 10-JUN-2024 (as of this past Monday), the patient began to break out into a rash that covered most of his body. On an unspecified date in 2024, he started to be fussy, and it was difficult to judge how he was doing. He also had a loss of appetite on an unspecified date in 2024. On 14-JUN-2024, the pediatrician was seen who saw the patient and recommended to give him paracetamol (TYLENOL) or ibuprofen (MOTRIN) as needed for pain and expected the rash to go away within a week or so. The patient had not been hospitalized or received any treatments regarding these adverse events. The reported stated that her son did not recover from their symptoms (events) as of the time of this report.  The causal relationship between all the events and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.  Lot number is being requested and will be submitted if available.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Biopsy skin, Blister, Herpes zoster, Skin lesion, Varicella
Clinical narrative: HERPES ZOSTER; CHICKENPOX; This spontaneous report was received from an Other Health Professional and refers to a currently 16-year-old male patient.  The patient's medical history included asthma, sickle cell disease, allogeneic stem cell transplantation,  graft versus host disease in GI tract,  Escherichia coli bacteremia,  pyogenic arthritis hip, and osteonecrosis. The patient's concurrent conditions included drug allergy. Historical drugs included morphine, and oxycodone. Concomitant medications included infliximab, phenoxymethylpenicillin potassium (PENICILLIN VK) and valaciclovir.   On 19-MAY-2009, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, administered for prophylaxis (lot # 0914Y, strength, expiry date, and route of administration were not provided). On 08-MAY-2013, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, 0.5 milliliter, lot #H015639, expiration date: 23-FEB-2014, administered for prophylaxis (strength and route of administration were not provided).  On an unknown date in 2016, the patient experienced chickenpox. On an unknown date, the patient experienced herpes zoster and was admitted to the hospital due to the event. On 22-JUN-2024, sample was obtained from skin vesicle/lesion (no result reported). The outcome of the events was not reported.  The causal relationship between the events and suspect products was not reported.
Sex: M
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: impaired response to Pneumovax-23 (vaccine failure); This literature marketed report has been received from the authors of a published article, and refers to a 74-year-old male patient.  The patient's medical history and concomitant therapies were not reported. The patient's concurrent conditions included X-linked agammaglobulinemia (XLA).  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced impaired response to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23). At the time of reporting, the outcome of the event was not provided.  The authors considered the event to be related to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).  Lot is being requested and will be submitted if received.  This is one of five reports derived from the same literature article (cross referenced with MARRS # 2407USA001987, 2407USA003226, 2407USA003228 and 2407USA003229).; Sender's Comments:  US-009507513-2407USA001987: US-009507513-2407USA003226: US-009507513-2407USA003228: US-009507513-2407USA003229:
Sex: M
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: impaired response to Pneumovax-23 (vaccine failure); This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a 47-year-old male patient.  The patient's medical history and concomitant therapies were not reported. The patient's concurrent conditions included IgG subclass deficiency.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced impaired response to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23). At the time of reporting, the outcome of the event was not provided.  The authors considered the event to be related to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).  A copy of the published article is attached as further documentation of the patient's experience.  Lot is being requested and will be submitted if received.  This is one of several reports derived from the same literature article (cross referenced with # 2407USA001987, 2407USA003226, 2407USA003227 and 2407USA003229).; Sender's Comments:  US-009507513-2407USA001987: US-009507513-2407USA003226: US-009507513-2407USA003227: US-009507513-2407USA003229:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE/no PQC reported; HBP called and reported a dose of ROTATEQ was administered to a patient after the product was involved in a temperature excursion. Caller stated no patient symptoms have been reported. Caller also provided information for additional patients who rece; This spontaneous report was received from an office manager and refers to a 4-month-old patient of unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 20-MAY-2024 the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1975783 and expiration date 12-OCT-2024 for prophylaxis (exact dose, dose number and route of administration were not provided). The temperature excursion lasted for 30 minutes in temperature of 8.94 Celsius degrees (C). Caller stated no patient symptoms have been reported (product storage error and no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Mobility decreased, Nausea, Somnolence
Clinical narrative: Besides the nausea; real drowsy all day long; can't hardly lift my arms; just feel out of it; I just feel drained; This non-serious case was reported by a consumer and described the occurrence of nausea in a 58-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included autoimmune deficiency syndrome. Concomitant products included gabapentin and topiramate.   On 28-JUN-2024, the patient received Shingles vaccine. On 28-JUN-2024, less than a day after receiving Shingles vaccine, the patient experienced nausea (Verbatim: Besides the nausea), drowsiness (Verbatim: real drowsy all day long), mobility decreased (Verbatim: can't hardly lift my arms), feeling abnormal (Verbatim: just feel out of it) and exhaustion (Verbatim: I just feel drained). The outcome of the nausea, drowsiness, mobility decreased, feeling abnormal and exhaustion were not resolved.   It was unknown if the reporter considered the nausea, drowsiness, mobility decreased, feeling abnormal and exhaustion to be related to Shingles vaccine.     It was unknown if the company considered the nausea, drowsiness, mobility decreased, feeling abnormal and exhaustion to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-JUN-2024 This report was submitted via the online direct entry reporting system. The case was reported by the patient. The patient received Shingles vaccine. The patient reported that besides the nausea, she was real drowsy all day long, could not hardly lift her arms, just felt out of it. The patient explained to the technician about her autoimmune deficiency, she just felt drained.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: shingles's like blisters on hands and feet elbow; This non-serious case was reported by a consumer and described the occurrence of vesicular rash in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-JUN-2024, the patient received the 1st dose of Shingrix. On 28-JUN-2024, 3 days after receiving Shingrix, the patient experienced vesicular rash (Verbatim: shingles's like blisters on hands and feet elbow). The outcome of the vesicular rash was not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.     It was unknown if the company considered the vesicular rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUN-2024 The patient self-reported this case for herself. The patient received Shingrix. The patient woke up with shingles like blisters on hands and feet elbow. The patient reported that she was a healthy active person.