chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Laboratory test, Leukocytosis, Magnetic resonance cholangiopancreatography, Pancreatitis acute, Pancreatitis necrotising
Clinical narrative: On 1/21 developed severe abdominal pain and intractable vomiting- went to a local Hospital and admitted with pancreatitis and leukocytosis . Developed into idiopathic acute necrotizing pancreatitis and developed bilateral pleural effusions and an ileus, required tertiary care center and was transferred to a local clinic on 1/26  for tachycardia with pulse reaching 170, respiratory distress requiring O2 at 6Liters. Was discharged 1/30/23 and on 2/5/2023 developed shortness of breath and severe abdominal pain and went to local ER and was found to have a large fluid collection around the pancreas requiring tertiary care center and he was transferred to another health care facility.  He required a NJ for nutrition. Had increased pain while there. Now has a second fluid collection. Has been in pain continuously. He also is now having left shoulder pain and is unable to lift/ move his arm. He is currently still inpatient
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pleural effusion, Respiratory distress, Tachycardia, Vomiting, X-ray
Clinical narrative: On 1/21 developed severe abdominal pain and intractable vomiting- went to a local Hospital and admitted with pancreatitis and leukocytosis . Developed into idiopathic acute necrotizing pancreatitis and developed bilateral pleural effusions and an ileus, required tertiary care center and was transferred to a local clinic on 1/26  for tachycardia with pulse reaching 170, respiratory distress requiring O2 at 6Liters. Was discharged 1/30/23 and on 2/5/2023 developed shortness of breath and severe abdominal pain and went to local ER and was found to have a large fluid collection around the pancreas requiring tertiary care center and he was transferred to another health care facility.  He required a NJ for nutrition. Had increased pain while there. Now has a second fluid collection. Has been in pain continuously. He also is now having left shoulder pain and is unable to lift/ move his arm. He is currently still inpatient
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Medication error, Product administration error
Clinical narrative: This was not an adverse event, but a medication error. The pharmacist never drew up the vaccine, resulting in ?administering? nothing upon injection. Not reported by pharmacy due to denial of the event.  Resulted in patient having records that indicate he was given his booster, however he was not.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Crying, Pyrexia, Tremor, Vomiting
Clinical narrative: Crying for hours in the evening after shot, 2 days later followed a fever. Day 5, shaking and vomiting.   The last DTAP vaccine he had the same reaction as well with vomiting and shaking.
Age: 82.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chromaturia, Computerised tomogram normal, Hypoaesthesia, Pollakiuria, Sleep deficit
Clinical narrative: Covid Booster & Flu shots were given at the same time in same L arm. 1. Reaction: within 2 weeks I noticed my urine looked like pain water and urination frequency was greatly increased. This has continued to present but in February I have had 4 nights of solid sleep. 2. Reaction" On 12/29/2023 I felt numbness creeping into the L side of my face from L side of my nose across my cheek. Both reactions seem to be waning. I am grateful especially for any solid nights sleep. Sleep deprivation seriously effects your ability to function. Also color has returned to my urine. I suspect the numbness in face may be Bell's Palsy but I experienced numbness but not paralysis.
Age: 82.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Urine abnormality
Clinical narrative: Covid Booster & Flu shots were given at the same time in same L arm. 1. Reaction: within 2 weeks I noticed my urine looked like pain water and urination frequency was greatly increased. This has continued to present but in February I have had 4 nights of solid sleep. 2. Reaction" On 12/29/2023 I felt numbness creeping into the L side of my face from L side of my nose across my cheek. Both reactions seem to be waning. I am grateful especially for any solid nights sleep. Sleep deprivation seriously effects your ability to function. Also color has returned to my urine. I suspect the numbness in face may be Bell's Palsy but I experienced numbness but not paralysis.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: On Feb 22, 2023, patient asked if "normal: for her arm to still hurt after getting a fly shot on 2-2-23. Advised patient to see her physician because pain usually subsides after 2 days.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Acupuncture, Balance disorder, Benign prostatic hyperplasia, Echocardiogram, Electrocardiogram
Clinical narrative: Adverse event: Loss of balance including numbness in feet and legs that traveled upward toward the waist. BPH symptoms with lower sensory weakness and numbness.   Treatment includes: 300 mg Gabapentin X 4 times a day / Meloxicam 15 mg 1 X per day ; reflexology and acupuncture  Outcome: Ongoing no relief
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging abdominal, Magnetic resonance imaging head, Magnetic resonance imaging neck
Clinical narrative: Adverse event: Loss of balance including numbness in feet and legs that traveled upward toward the waist. BPH symptoms with lower sensory weakness and numbness.   Treatment includes: 300 mg Gabapentin X 4 times a day / Meloxicam 15 mg 1 X per day ; reflexology and acupuncture  Outcome: Ongoing no relief
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal, Muscular weakness, Reflexology
Clinical narrative: Adverse event: Loss of balance including numbness in feet and legs that traveled upward toward the waist. BPH symptoms with lower sensory weakness and numbness.   Treatment includes: 300 mg Gabapentin X 4 times a day / Meloxicam 15 mg 1 X per day ; reflexology and acupuncture  Outcome: Ongoing no relief
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Chromosome analysis normal, Exposure during pregnancy, Foetal death, Foetal heart rate abnormal, Medical procedure
Clinical narrative: In December 1996, I had just found out I was pregnant and was in for the first ultrasound at clinic. It was confirmed and the fetus had a heart beat. The fetus was normal and thriving for 8 weeks of development.   The doctor gave me the flu vaccine.  2 weeks later, I was at clinic, for a routine pregnancy check. They found no heart beat and said that the fetus was age 8 weeks and no longer living, even though we were at 10 weeks pregnancy (it was January 1997).   They transferred me to the hospital and had to remove the baby. They asked if I wanted to have the fetus studied to see potential cause.  I did. The fetus was chromosomally normal, age 8 weeks from conception, a girl, and had been dead for 2 weeks. I didn't figure it out then, but now I suspect that the flu vaccine killed my fetus, and since that is an unnatural way to die, that is why I didn't have a miscarriage but had to have the fetus removed. Have you studied babies that die in utero and that the mother carries around for weeks to see how many correlate with instant death after a vaccine? If you haven't you should.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Nerve injury
Clinical narrative: lost hearing in left ear completely and permantly with nerve being dead
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event
Clinical narrative: The patient did not experience any adverse events
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Injection site rash, Lymph node pain, Lymphadenopathy, Rash
Clinical narrative: Swollen painful lymph nodes under arm and by collar bone on the same arm as vaccine was given  Covid arm rash began on arm where injection was given
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Patient stated she started having injection site pain after receiving vaccine. She then stated she started having pain from her neck to down her right arm. She has tried to take ibuprofen and rotated between ice/heat packs. It has been 7 days and she is still experiencing a loss of movement in her right arm.
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: Laboratory test abnormal, Oxygen saturation decreased
Clinical narrative: My son's oxygen dropped in December 2022.  Normal was 97-100 dropped to 92-95.  February 5 2023 rushed to ER and discovered he has PE.  I'm just looking for any answer that could have caused the PE. I believe in the vaccines and I'm just trying as a mother to figure out what happened.  My son has cp but is considered very healthy. I just find it very strange that he all of a sudden developed PE.  I'm just need some data.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac monitoring, Cerebral infarction, Echocardiogram, Magnetic resonance imaging, Muscular weakness
Clinical narrative: left leg weakness, diagnosed with right ACA infarction
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Immunisation reaction, Injection site erythema, Injection site induration, Menstrual disorder
Clinical narrative: Severe Covid Arm - redness and hardening around booster site on left arm, disruption of menstrual cycle for 1 year: low grade constant period/heaving spotting, heart pulpitations.  Starting Jan 2023, vaginal bleeding for 1 straight month.  Starting Feb 2023, involuntary muscle spasms on left face (under eye).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea, Palpitations
Clinical narrative: Severe Covid Arm - redness and hardening around booster site on left arm, disruption of menstrual cycle for 1 year: low grade constant period/heaving spotting, heart pulpitations.  Starting Jan 2023, vaginal bleeding for 1 straight month.  Starting Feb 2023, involuntary muscle spasms on left face (under eye).
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Electrocardiogram, Electroencephalogram, Laboratory test, Palpitations
Clinical narrative: severe heart pulpitations
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Wrong dose was given. Patient has not received initial Pfizer vaccine.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: injection site reaction below injection site, began when patient went home, continues to improve since onset
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Unevaluable event
Clinical narrative: unknown- unable to contact this case due to hospitalization.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given after beyond usage date on packaging. Patient did not experience any adverse signs or symtoms.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given vaccine after beyond use date on packaging. Patient did not experience any adverse signs or symptoms.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given vaccine after beyond use date on packaging. Patient did not experience any adverse signs or symptoms.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given vaccine after beyond use date on packaging. Patient did not experience any adverse signs or symptoms.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given vaccine after beyond use date on packaging. Patient did not experience any adverse signs or symptoms.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, Dementia, SARS-CoV-2 test positive
Clinical narrative: DEATH CERTIFICATE LISTS "COVID-19, OLD CVA, AND DEMENTIA" AS THE CAUSE OF DEATH.  PATIENT WAS A RESIDENT AT LTCF WHEN DEATH OCCURRED.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Decreased appetite, Diarrhoea, Mood altered, Pyrexia
Clinical narrative: Diarrhea, fever, loss of appetite and ongoing severe change in mood
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, COVID-19, Cerebrovascular accident, Chronic kidney disease, Condition aggravated
Clinical narrative: PATIENT ADMITTED TO HOSPITAL ON 7/9/22 FROM OUTSIDE FACILITY FOR AN AKI ON TOP OF HER CKD. SHE WAS COVID-19+ AT TIME OF ADMISSION AND REQUIRING OXYGEN. PATIENT HAD RECURRENT STROKES, GI BLEED, AND ACUTE ON CKD. PATIENT DECLINED DURING ADMISSION AND WAS TRANSITIONED TO DNR/DNI AND THEN MADE COMFORTABLE. PATIENT DIED 8/2/2022.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Gastrointestinal haemorrhage, SARS-CoV-2 test positive
Clinical narrative: PATIENT ADMITTED TO HOSPITAL ON 7/9/22 FROM OUTSIDE FACILITY FOR AN AKI ON TOP OF HER CKD. SHE WAS COVID-19+ AT TIME OF ADMISSION AND REQUIRING OXYGEN. PATIENT HAD RECURRENT STROKES, GI BLEED, AND ACUTE ON CKD. PATIENT DECLINED DURING ADMISSION AND WAS TRANSITIONED TO DNR/DNI AND THEN MADE COMFORTABLE. PATIENT DIED 8/2/2022.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fall, Fracture treatment, Upper limb fracture
Clinical narrative: Case had a fall fractured arm which required surgical repair.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Pt called stating two days after second Shingrix vaccine developed rash and redness on back and legs. Recommended to take Benadryl and have PCP or urgent care examine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain, Pyrexia
Clinical narrative: The first day following the injection, aches and muscle pain, fever of 99.5. The following day joint aches and muscle pain and fever of 101.5.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Flu-like symptoms, headache, low-grade fever, very sore muscles/joints, loss of appetite, vomiting, diarrhea, dizzy, temporary loss of taste, continued random sharp/stabbing pains in various locations all over body with greater intensity.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Pain, Pyrexia
Clinical narrative: Flu-like symptoms, headache, low-grade fever, very sore muscles/joints, loss of appetite, vomiting, diarrhea, dizzy, temporary loss of taste, continued random sharp/stabbing pains in various locations all over body with greater intensity.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Flu-like symptoms, headache, low-grade fever, very sore muscles/joints, loss of appetite, vomiting, diarrhea, dizzy, temporary loss of taste, continued random sharp/stabbing pains in various locations all over body with greater intensity.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphagia, Pruritus, Throat tightness
Clinical narrative: Patient reported entire body itching, tight throat, and difficulty swallowing. She took Benadryl at 2:00 AM on this morning February 26, 2023 and again about two hours before being seen in the clinic today. She reported only mild and temporary relief with Benadryl and still continues to experience itching sensation all over her body and a tight throat. Patient referred to higher care of service to the local ER for further evaluation.
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Upon revieweing the expiration date for Phizer-Biontech covid 19 vaccine, bivalent (NDC 59267-0304-02), find out that pharmacist was accidentally gave expired vaccine to patient. Lot #GJ6739 extended expiration date 1/31/24. Date took out from Cooler (@-90 to -60C) was 11/21/22. Beyond use date (@2 to 8C) was 1/31/23 (10 weeks or 70th day). Date given to patient was 1/31/23 (71st day). Reached out Pfizer Manufacturer for guidance for information about vaccine stability. According to Pfizer medical information, recommended/labeled storage time in the prescribing information and excursion time. Vaccine was stable for total time of 72 hours = (10 weeks or 70 days labeled time plus 2 days excursion time) at temperature of 2 - 8 C. Unable to reach out patient at this time but left voicemail.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Computerised tomogram head abnormal, Confusional state, Death, Dizziness
Clinical narrative: October 7, 2022, Patient got very dizzy, could not walk, confused, blank stare and could barely talk.  Fire Dept. responded and transported patient to Hospital.  CT Scan completed and discovered a blood clot near the brain.  Transported by helicopter to different Hospital.  A Thrombectomy was completed and partial blood clot was removed.  Blood clots were then discovered in the right leg, right arm, both lungs and another in the brain, not counting what was already removed.  No explanation as to why the blood clots formed. Patient later passed away on October 20, 2022.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Gait inability, Magnetic resonance imaging, Pulmonary thrombosis, Speech disorder
Clinical narrative: October 7, 2022, Patient got very dizzy, could not walk, confused, blank stare and could barely talk.  Fire Dept. responded and transported patient to Hospital.  CT Scan completed and discovered a blood clot near the brain.  Transported by helicopter to different Hospital.  A Thrombectomy was completed and partial blood clot was removed.  Blood clots were then discovered in the right leg, right arm, both lungs and another in the brain, not counting what was already removed.  No explanation as to why the blood clots formed. Patient later passed away on October 20, 2022.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Staring, Thrombectomy, Thrombosis
Clinical narrative: October 7, 2022, Patient got very dizzy, could not walk, confused, blank stare and could barely talk.  Fire Dept. responded and transported patient to Hospital.  CT Scan completed and discovered a blood clot near the brain.  Transported by helicopter to different Hospital.  A Thrombectomy was completed and partial blood clot was removed.  Blood clots were then discovered in the right leg, right arm, both lungs and another in the brain, not counting what was already removed.  No explanation as to why the blood clots formed. Patient later passed away on October 20, 2022.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Developed tinnitus in right ear.  Noise level varies, from soft to fairly loud, but is constantly present.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Biopsy breast, Bone scan, Breast cancer female, Breast conserving surgery, Cytogenetic analysis
Clinical narrative: Breast Cancer diagnosed December 2022; lumpectomy January 2023
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging, Mammogram, Oncotype test, Ultrasound breast
Clinical narrative: Breast Cancer diagnosed December 2022; lumpectomy January 2023
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure during pregnancy, Induced labour, SARS-CoV-2 test positive
Clinical narrative: 11/15/21 presents for "scheduled late term IOL", "G1P0 at 41w3d".  PMHx" asthma, CIN III, hypothyroidism, psoriasis".
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: RUNNY NOSE, SORE THROAT, COUGH, DIARRHEA
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Injection site hypoaesthesia, Injection site pain, Muscular weakness, Pain, X-ray limb
Clinical narrative: Pain and weakness left shoulder radiating down to my hand, wakes me every night with pain. since that last covid vaccination, had also flu shot the same day. Pain continues every day since the last covid vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Asthenia, Injection site pain, Injection site reaction, Pain, Sleep disorder
Clinical narrative: Pain and weakness left shoulder radiating down to my hand, wakes me every night with pain. since that last covid vaccination, had also flu shot the same day. Pain continues every day since the last covid vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, COVID19, COVID19, COVID19-2
Symptoms: X-ray
Clinical narrative: Pain and weakness left shoulder radiating down to my hand, wakes me every night with pain. since that last covid vaccination, had also flu shot the same day. Pain continues every day since the last covid vaccine.
Age: 12.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Vaccination error, Wrong product administered
Clinical narrative: There was a oversight at looking at the system and patient was given 2nd dose of Menveo, she should have been given 2nd dose of HPV, caregiver was notified, no adverse reactions were noted by parent, advised she will still need the 2nd dose of HPV.
Age: 12.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: There was a oversight at looking at the system and patient was given 2nd dose of Menveo, she should have been given 2nd dose of HPV, caregiver was notified, no adverse reactions were noted by parent, advised she will still need the 2nd dose of HPV.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a nurse referring to multiple patients of unknown age and gender. The patients' concurrent conditions, historical conditions, concomitant therapies, and allergies were not reported.  On unspecified multiples dates, the multiple patients were vaccinated with varicella virus (OKA/MERCK) live attenuated [MRC-5 cells] (VARIVAX) (lot no. W008711 has been verified to be a valid lot number, expiration date: 14-MAR-2024) (dose, route of administration, vaccination scheme frequency, and anatomical location were not reported) for prophylaxis after a temperature excursion (Product storage error). The administered dose of the vaccine experienced a temperature excursion at -10.5 degrees Celsius for 1 hour and 34 minutes. There was no previous temperature excursion. No additional adverse event (AE) reported.    This report was classified as non-valid due to the lack of patient's identifiers and as it concern to multiple patients.  Follow-up information has been received from a nurse on 08-FEB-2023.   This spontaneous report has been received from a nurse, regarding to a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 12-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number W008711 which has been verified to be valid, expiration date reported and validated as 14-MAR-2024) (strength, dose, vaccination scheme frequency, route of administration, and anatomical sites of injection were not reported) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  and diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) (strengths, doses, vaccination scheme frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported). All of the vaccines were administered as prophylaxis.  Administered doses were stored at a temperature of -10.5 degrees Celsius (C) during a time frame of 1 hour and 34 minutes. There was no previous temperature excursion.  No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA004610: US-009507513-2302USA004609: US-009507513-2302USA004606: US-009507513-2302USA004607:
Age: 17.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Zostavax "VZV" was administered to a 17-year-old patient; Literature Report.  This literature marketed report as received from the authors of a published literature article, titled as stated above, and refers to a 17-year-old female with congenital Shone complex with post-operative complications resulting in moderate heart failure with reduced ejection fraction (HFrEF; EF less than 40%).  On an unknown date in 2009, the patient was vaccinated with influenza vaccine, measles, mumps and rubella  (Wistar RA 27-3) Virus Vaccine, Live (MMR), diphtheria vaccine toxoid, pertussis vaccine acellular, polio vaccine inact and tetanus vaccine toxoid (DTaP/IPV) and zoster Vaccine Live (VZV) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported) (product administered to patient of inappropriate age).  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no adverse event; 1 Separate, Improperly Stored VAQTA Dose was administered to 1 Corresponding Patient; This spontaneous report has been received from other reporter, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 10-FEB-2023, the patient was vaccinated with an improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection once as prophylaxis (lot number: W020525, which was determined to be valid, with an expiration date on 14-DEC-2023) (product storage error). The administered dose underwent a temperature excursion of 30.9 degrees Fahrenheit (F) for 4 hours and 30 minutes. No previous temperature excursion occurred, and no additional adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA007648: US-009507513-2302USA007649:
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available. No additional AE reported.; Nurse reports products that experienced temperature excursion over the weekend were administered to a patient.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. The patient's concomitant medication included sterile diluent.  On 13-FEB-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot #W029899, expiration date: 16-MAY-2024), varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #W024335, expiration date: 01-AUG-2024) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (lot #W012118, expiration date: 24-DEC-2023, therapy type: rHA) (all products were administered for prophylaxis, dose was unknown, strength and route of administration were not provided) that were improperly stored (product storage error). The vaccines hepatitis a vaccine, inactivated (VAQTA) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was exposed to above 9 degrees Celsius for 2 hours 32 minutes 0 seconds. No previous excursion. The vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to minus 10 degrees Celsius up to 8 degrees Celsius for 1 hour 40 minutes 0 seconds. No previous excursion. No additional adverse event (AE) details were available (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; 2 Separate, Improperly Stored GARDASIL 9 Doses were administered to 2 Separate Patients on 02/10/2023. Improperly Stored / Administered Vaccine; This spontaneous report has been received from a consumer, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 10-FEB-2023, the patient was vaccinated with an improperly storage dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection as prophylaxis (lot number: W011321, which was determined to be valid, with an expiration date on 09-NOV-2024) (product storage error) (strength, dose, scheme, route and anatomical location of administration were not reported). The administered dose underwent a temperature excursion of 30.9 degrees Fahrenheit (F) for 4 hours and 30 minutes. No previous temperature excursion occurred, and no additional adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA005112: US-009507513-2302USA007649:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no adverse event; 2 Separate, Improperly Stored GARDASIL 9 Doses were administered to 2 Separate Patients on 02/10/2023. Improperly Stored / Administered Vaccine; This spontaneous report has been received from a consumer, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 10-FEB-2023, the patient was vaccinated with an improperly storage dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection as prophylaxis (lot number: U029033, which was determined to be valid, with an expiration date on 13-MAR-2024) (product storage error) (strength, dose, scheme, route and anatomical location of administration were not reported). The administered dose underwent a temperature excursion of 30.9 degrees Fahrenheit (F) for 4 hours and 30 minutes. No previous temperature excursion occurred, and no additional adverse event was reported.  This is one of several reports received from the same reporter.   ; Sender's Comments:  US-009507513-2302USA005112: US-009507513-2302USA007648: US-009507513-2302USA005112:
Age: 73.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Chest discomfort, Chest pain, Herpes zoster, Pain
Clinical narrative: Shingles/ flu shot  Sharp radiating pressure chest pain.pain   every 4 to 5 hours
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood creatine, Blood creatine phosphokinase increased, Blood test, Dermatomyositis
Clinical narrative: -1st Moderna Booster November 9, 2021 -  Lot# 048C21A -From November 9 - May 12 - patient was previously independent, driving and living in own home, walking 40 mins per day/5 x per week and attending senior exercise classes.  -2nd Moderna Booster May 12, 2022 - as indicated above -Patient complained of fatigue, muscle instability while walking, minor falls -6/27/28 - patient got up in the middle of the night to go to the toilet. Unable to stand. Was sitting on the toilet for 11 hours until someone heard her and came to help. Throughout 6/27 and 6/28 patient unable to sit to stand in chairs - requiring ENT callout assistance (twice). ENT convinced patient to go to ED on 3rd callout.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dysstasia, Fall, Fatigue, Gait disturbance
Clinical narrative: -1st Moderna Booster November 9, 2021 -  Lot# 048C21A -From November 9 - May 12 - patient was previously independent, driving and living in own home, walking 40 mins per day/5 x per week and attending senior exercise classes.  -2nd Moderna Booster May 12, 2022 - as indicated above -Patient complained of fatigue, muscle instability while walking, minor falls -6/27/28 - patient got up in the middle of the night to go to the toilet. Unable to stand. Was sitting on the toilet for 11 hours until someone heard her and came to help. Throughout 6/27 and 6/28 patient unable to sit to stand in chairs - requiring ENT callout assistance (twice). ENT convinced patient to go to ED on 3rd callout.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Grip strength decreased, Immobile, Immunoglobulin therapy, Impaired self-care
Clinical narrative: -1st Moderna Booster November 9, 2021 -  Lot# 048C21A -From November 9 - May 12 - patient was previously independent, driving and living in own home, walking 40 mins per day/5 x per week and attending senior exercise classes.  -2nd Moderna Booster May 12, 2022 - as indicated above -Patient complained of fatigue, muscle instability while walking, minor falls -6/27/28 - patient got up in the middle of the night to go to the toilet. Unable to stand. Was sitting on the toilet for 11 hours until someone heard her and came to help. Throughout 6/27 and 6/28 patient unable to sit to stand in chairs - requiring ENT callout assistance (twice). ENT convinced patient to go to ED on 3rd callout.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle disorder, Muscular weakness, Musculoskeletal disorder, Myositis
Clinical narrative: -1st Moderna Booster November 9, 2021 -  Lot# 048C21A -From November 9 - May 12 - patient was previously independent, driving and living in own home, walking 40 mins per day/5 x per week and attending senior exercise classes.  -2nd Moderna Booster May 12, 2022 - as indicated above -Patient complained of fatigue, muscle instability while walking, minor falls -6/27/28 - patient got up in the middle of the night to go to the toilet. Unable to stand. Was sitting on the toilet for 11 hours until someone heard her and came to help. Throughout 6/27 and 6/28 patient unable to sit to stand in chairs - requiring ENT callout assistance (twice). ENT convinced patient to go to ED on 3rd callout.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Rash, Rash erythematous, Sitting disability, Troponin increased
Clinical narrative: -1st Moderna Booster November 9, 2021 -  Lot# 048C21A -From November 9 - May 12 - patient was previously independent, driving and living in own home, walking 40 mins per day/5 x per week and attending senior exercise classes.  -2nd Moderna Booster May 12, 2022 - as indicated above -Patient complained of fatigue, muscle instability while walking, minor falls -6/27/28 - patient got up in the middle of the night to go to the toilet. Unable to stand. Was sitting on the toilet for 11 hours until someone heard her and came to help. Throughout 6/27 and 6/28 patient unable to sit to stand in chairs - requiring ENT callout assistance (twice). ENT convinced patient to go to ED on 3rd callout.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Walking aid user, Wheelchair user
Clinical narrative: -1st Moderna Booster November 9, 2021 -  Lot# 048C21A -From November 9 - May 12 - patient was previously independent, driving and living in own home, walking 40 mins per day/5 x per week and attending senior exercise classes.  -2nd Moderna Booster May 12, 2022 - as indicated above -Patient complained of fatigue, muscle instability while walking, minor falls -6/27/28 - patient got up in the middle of the night to go to the toilet. Unable to stand. Was sitting on the toilet for 11 hours until someone heard her and came to help. Throughout 6/27 and 6/28 patient unable to sit to stand in chairs - requiring ENT callout assistance (twice). ENT convinced patient to go to ED on 3rd callout.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram cerebral abnormal, Anticoagulant therapy, Arteriogram carotid abnormal, Cardiac disorder, Cardiac monitoring
Clinical narrative: The patient had a brain stroke after getting the medicine. one of the arteries in the brain had small blood clots to form. Patient had a vaccine shot on 30th September 2022 at 12:30 p.m. Immediately she had some tingling  in her neck which she ignored. Then next day, she started to see "blackouts". After following day, she started seeing colors. At that time, she was admitted to the Emergency. Patient mentioned to the doctors about Covid vaccine - however all the doctors (whether ER, ENT, Neurology) ignored and did not want to make this as Covid Vaccine adverse reaction. Patient was put on two blood thinners (one - Plavix for 3 months and second - Aspirin for life long). Because Doctors did not want to admit this as a adverse effect of Covid Vaccine, they assumed that this was because of Heart. Put a monitor to monitor any irregular heart beat. Doctors did not put any follow up after three months (when the blood thinner Plavix will be stopped).  Patient flew. Patient got another brain stroke on 8th Feb and the DOctors at Hospital conducted CT Angioscan of Brain and Neck, Holter Test, and other test to rule out any other cause. Now doctors confirmed that this was an ischemic stroke. Patient has now the right side of cerebral artery is 80% blocked and right side is 30%.  Patient is so frustated that now she may need a strent to unblock the arteries so the blood can flow in brain.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Carotid artery stenosis, Cerebral artery embolism, Cerebral artery occlusion, Cerebral artery stenosis, Cerebral artery thrombosis
Clinical narrative: The patient had a brain stroke after getting the medicine. one of the arteries in the brain had small blood clots to form. Patient had a vaccine shot on 30th September 2022 at 12:30 p.m. Immediately she had some tingling  in her neck which she ignored. Then next day, she started to see "blackouts". After following day, she started seeing colors. At that time, she was admitted to the Emergency. Patient mentioned to the doctors about Covid vaccine - however all the doctors (whether ER, ENT, Neurology) ignored and did not want to make this as Covid Vaccine adverse reaction. Patient was put on two blood thinners (one - Plavix for 3 months and second - Aspirin for life long). Because Doctors did not want to admit this as a adverse effect of Covid Vaccine, they assumed that this was because of Heart. Put a monitor to monitor any irregular heart beat. Doctors did not put any follow up after three months (when the blood thinner Plavix will be stopped).  Patient flew. Patient got another brain stroke on 8th Feb and the DOctors at Hospital conducted CT Angioscan of Brain and Neck, Holter Test, and other test to rule out any other cause. Now doctors confirmed that this was an ischemic stroke. Patient has now the right side of cerebral artery is 80% blocked and right side is 30%.  Patient is so frustated that now she may need a strent to unblock the arteries so the blood can flow in brain.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebral infarction, Cerebrovascular accident, Computerised tomogram head normal, Dyschromatopsia, Electrocardiogram ambulatory
Clinical narrative: The patient had a brain stroke after getting the medicine. one of the arteries in the brain had small blood clots to form. Patient had a vaccine shot on 30th September 2022 at 12:30 p.m. Immediately she had some tingling  in her neck which she ignored. Then next day, she started to see "blackouts". After following day, she started seeing colors. At that time, she was admitted to the Emergency. Patient mentioned to the doctors about Covid vaccine - however all the doctors (whether ER, ENT, Neurology) ignored and did not want to make this as Covid Vaccine adverse reaction. Patient was put on two blood thinners (one - Plavix for 3 months and second - Aspirin for life long). Because Doctors did not want to admit this as a adverse effect of Covid Vaccine, they assumed that this was because of Heart. Put a monitor to monitor any irregular heart beat. Doctors did not put any follow up after three months (when the blood thinner Plavix will be stopped).  Patient flew. Patient got another brain stroke on 8th Feb and the DOctors at Hospital conducted CT Angioscan of Brain and Neck, Holter Test, and other test to rule out any other cause. Now doctors confirmed that this was an ischemic stroke. Patient has now the right side of cerebral artery is 80% blocked and right side is 30%.  Patient is so frustated that now she may need a strent to unblock the arteries so the blood can flow in brain.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Foreign travel, Frustration tolerance decreased, Immediate post-injection reaction, Ischaemic stroke, Laboratory test
Clinical narrative: The patient had a brain stroke after getting the medicine. one of the arteries in the brain had small blood clots to form. Patient had a vaccine shot on 30th September 2022 at 12:30 p.m. Immediately she had some tingling  in her neck which she ignored. Then next day, she started to see "blackouts". After following day, she started seeing colors. At that time, she was admitted to the Emergency. Patient mentioned to the doctors about Covid vaccine - however all the doctors (whether ER, ENT, Neurology) ignored and did not want to make this as Covid Vaccine adverse reaction. Patient was put on two blood thinners (one - Plavix for 3 months and second - Aspirin for life long). Because Doctors did not want to admit this as a adverse effect of Covid Vaccine, they assumed that this was because of Heart. Put a monitor to monitor any irregular heart beat. Doctors did not put any follow up after three months (when the blood thinner Plavix will be stopped).  Patient flew. Patient got another brain stroke on 8th Feb and the DOctors at Hospital conducted CT Angioscan of Brain and Neck, Holter Test, and other test to rule out any other cause. Now doctors confirmed that this was an ischemic stroke. Patient has now the right side of cerebral artery is 80% blocked and right side is 30%.  Patient is so frustated that now she may need a strent to unblock the arteries so the blood can flow in brain.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging head abnormal, Paraesthesia, Vertebral artery stenosis, Visual impairment
Clinical narrative: The patient had a brain stroke after getting the medicine. one of the arteries in the brain had small blood clots to form. Patient had a vaccine shot on 30th September 2022 at 12:30 p.m. Immediately she had some tingling  in her neck which she ignored. Then next day, she started to see "blackouts". After following day, she started seeing colors. At that time, she was admitted to the Emergency. Patient mentioned to the doctors about Covid vaccine - however all the doctors (whether ER, ENT, Neurology) ignored and did not want to make this as Covid Vaccine adverse reaction. Patient was put on two blood thinners (one - Plavix for 3 months and second - Aspirin for life long). Because Doctors did not want to admit this as a adverse effect of Covid Vaccine, they assumed that this was because of Heart. Put a monitor to monitor any irregular heart beat. Doctors did not put any follow up after three months (when the blood thinner Plavix will be stopped).  Patient flew. Patient got another brain stroke on 8th Feb and the DOctors at Hospital conducted CT Angioscan of Brain and Neck, Holter Test, and other test to rule out any other cause. Now doctors confirmed that this was an ischemic stroke. Patient has now the right side of cerebral artery is 80% blocked and right side is 30%.  Patient is so frustated that now she may need a strent to unblock the arteries so the blood can flow in brain.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No symptomatic side effects reported during time of call. No additional AE details or PQC.; a patient was administered VARIVAX intramuscularly instead of subcutaneously; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.  On 14-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous Injection with sterile diluent (strength, dose, frequency, lot# and expiration date were not provided) intramuscularly instead of subcutaneously for prophylaxis (incorrect route of product administration). No symptomatic side effects reported during time of call. No additional adverse event (AE) details or product quality complaint (PQC).
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix Administerd; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 16th February 2023, the patient received the 1st dose of Havrix. On 16th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-FEB-2023 Reporter's Comment: The reporter reported that he was notified that a patient was administered a dose of Havrix, which had an expiration date of 30th September 2022.  This was the patient's first dose in the series.  At the time of reporting, the patient was not been redosed.  The reporter consented to follow up. Additional Supportive Information: The patient administered an expired Havrix dose, which led to Expired vaccine used.
Age: 64.0
Sex: M
Vaccine: COVID19-2, FLUR4
Symptoms: Medication error, Product storage error
Clinical narrative: Medication error. Covid vaccine not viable due to improper temperature storage.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Medication error, Product storage error
Clinical narrative: Medication error. Vaccine not viable due to improper temperature storage.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death on 02/12/2023
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: saline vial drawn and given, did not mix with second vial.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Medication error, Product storage error
Clinical narrative: Medication error. Vaccine not viable due to improper temperature storage.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Computerised tomogram, Electromyogram, Fatigue, Inflammatory marker test, Influenza like illness
Clinical narrative: Flu like symptoms extreme fatigue and fever and malaise and myaglias.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Laboratory test, Magnetic resonance imaging, Malaise, Myalgia, Nerve conduction studies
Clinical narrative: Flu like symptoms extreme fatigue and fever and malaise and myaglias.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Pyrexia, Spinal myelogram
Clinical narrative: Flu like symptoms extreme fatigue and fever and malaise and myaglias.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Medication error, Product storage error
Clinical narrative: Medication error. Vaccine not viable due to improper temperature storage.
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Medication error, Product storage error
Clinical narrative: Medication error. Vaccine not viable due to improper temperature storage.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Malaise, Pain in extremity, Respiratory tract congestion
Clinical narrative: For about 24 hours after receiving the vaccine, I was tired and had a sore arm. I started not feeling well on 12/08/2022 with congestion and sneezing. I tested positive for COVID-19 on 12/12/2022. By the time I tested positive for COVID-19 I was passed the recommended time to start the medication. I also tested positive for COVID-19 on 12/27/2021.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sneezing
Clinical narrative: For about 24 hours after receiving the vaccine, I was tired and had a sore arm. I started not feeling well on 12/08/2022 with congestion and sneezing. I tested positive for COVID-19 on 12/12/2022. By the time I tested positive for COVID-19 I was passed the recommended time to start the medication. I also tested positive for COVID-19 on 12/27/2021.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient given monovalent vaccine instead of bivalent as booster dose
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Medication error, Product storage error
Clinical narrative: Medication error. Vaccine not viable due to improper temperature storage.