chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Secretion discharge, Sinus pain
Clinical narrative: I mostly had thick mucus, sinus pain, congestion ,and a little cough. I  tested positive at home for COVID-19. I took mucinex and Sudafed. I called the doctor and was prescribed Paxlovid. I had to go to the ER because I was having chest pain. After I was done taking Paxlovid I tested negative  on the 16th and then on the 22nd I tested positive again. I had the same symptoms as before and I tested negative on the 29th. I still have more nasal drainage than before.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, Pyrexia, SARS-CoV-2 test positive, Sneezing
Clinical narrative: I tested positive for COVID-19, August 23, 2022. I had really mild symptoms. I was sneezing a lot and a slight fever around 99.  I contacted my doctor the same day and he prescribe me Paxlovid the same day. I was instructed to take the Paxlovid for five days straight.
Age: 1.83
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 104 persistent for 48 hours
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral normal, Basal ganglia haemorrhage, Cerebral haemorrhage, Computerised tomogram head abnormal, Hemiplegia
Clinical narrative: Patient presented to ED on 2/26/22 with right hemiplegia, CT head found a left basal ganglia hemorrhage. Follow-up imaging studies and a recent cerebral angio  performed on 9/22/22, failed to reveal evidence of any aneurysm, early venous drainage, nidus, dissection, vasculitis, vasospasm or tumor blush was identified which would explain her spontaneous ICH.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Imaging procedure
Clinical narrative: Patient presented to ED on 2/26/22 with right hemiplegia, CT head found a left basal ganglia hemorrhage. Follow-up imaging studies and a recent cerebral angio  performed on 9/22/22, failed to reveal evidence of any aneurysm, early venous drainage, nidus, dissection, vasculitis, vasospasm or tumor blush was identified which would explain her spontaneous ICH.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: MA approached RN regarding Expiration date on COVID 5-11 vaccine. Coming up in system as 9/30/2022, Beyond use date shows as 10/14. Was taught by previous RN that we use the Beyond use date. We gave vaccine to child 5 days after expiration. Pfizer called and verified with RN the 9/30 date is what we should follow, was not able to give any information regarding the vaccine given and if patient should be revaccinated, sent nurse to CDC website which states, "Contact the manufacturer for information on the stability of the vaccine. If the manufacturer does not have data to support the stability of the vaccine, repeat the dose immediately (no minimum interval)" Doctor notified immediately about the above incident and reccomendations that were given, she was not concerned and will repeat the vaccine at 3 weeks. The rest of the vaccine was removed from the fridge and wasted. New vaccine was ordered.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Autopsy, Death, Malaise
Clinical narrative: Had covid symptoms and dead within one month
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: PT WAS ON SCHEDULE TO RECEIVE THE PFIZER BIVALENT INJECTION TODAY;  NOT KNOW THAT THE AGE GROUP OF 5-11 ARE ONLY SUPPOSED TO RECEIVE 3SHOTS, STAFF GAVE HER A 4TH COVID INJECTION. STAFF MONITORED PT FOR 30MINS TO MAKE SURE SHE HAD NO ADVERSE REACTIONS OR SIDE EFFECTS.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event, patient was under the recommended age of 65 for receiving the HD fluzone vaccine.
Age: 81.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Incorrect dose administered, No adverse event, Pain in extremity
Clinical narrative: No adverse event was experienced. There was a dosing administration error.  0.5ml was injected instead of 0.3ml.  No adverse events other than arm being a little sore, which is expected with the normal dose.
Age: 81.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Interchange of vaccine products, Overdose, Pain in extremity
Clinical narrative: No adverse event was experienced. There was a dosing administration error.  0.5ml was injected instead of 0.3ml.  No adverse events other than arm being a little sore, which is expected with the normal dose.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The Monovalent Pfizer was administered on accident instead of bivalent Pfizer
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Back pain, Gait disturbance, Hypophagia, Pyrexia
Clinical narrative: I had a fever of 100, and severe stomach pain that hurt all the way to my back. It doesn't hurt as bad now at least I am able to walk now. I was hurting so bad that I had to take my pain medication every two hours instead of every four hours. VALIUM seemed to help more because it relaxes the muscles. I can barely eat anything still. It has to be very bland, soft food.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent Pfizer administered on accident instead of bivalent Pfizer
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Chills, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Around 9 to 10 pm, sore arm developed. Over an hour or so the pain spread to the other arm and then throughout the whole body.  Fever and chills also developed. Pain described as debilitating. Vomiting started around 2 am. Vomiting several times over the course of 3 hours. Pt unsure if she ate something bad or not. No problems with breathing. No allergic reaction like symptoms, but patient takes benadryl OTC. Pt unable to leave bed until 3pm. Still currently feeling sore throughout body. Pt's last migraine 2 weeks ago, lasted about an hour.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Vomiting
Clinical narrative: Around 9 to 10 pm, sore arm developed. Over an hour or so the pain spread to the other arm and then throughout the whole body.  Fever and chills also developed. Pain described as debilitating. Vomiting started around 2 am. Vomiting several times over the course of 3 hours. Pt unsure if she ate something bad or not. No problems with breathing. No allergic reaction like symptoms, but patient takes benadryl OTC. Pt unable to leave bed until 3pm. Still currently feeling sore throughout body. Pt's last migraine 2 weeks ago, lasted about an hour.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent Pfizer administered on accident instead of bivalent Pfizer
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent Pfizer administered on accident instead of bivalent Pfizer
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test abnormal, Chills, Computerised tomogram normal, Culture urine positive, Fibrin D dimer increased
Clinical narrative: I started with chills a shore arm and a headache and then my pulse kept getting higher to 103 then I counted and it was 120 or something at night. and in the morning I still had it, I was concerned about the clotting issue but the racing heart was making  I should  get checked out. So I went to the ER. It's been 12 hours of my heart going that fast.  they gave me a liter of fluid.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Heart rate increased, Pain in extremity, Palpitations, Scan with contrast normal
Clinical narrative: I started with chills a shore arm and a headache and then my pulse kept getting higher to 103 then I counted and it was 120 or something at night. and in the morning I still had it, I was concerned about the clotting issue but the racing heart was making  I should  get checked out. So I went to the ER. It's been 12 hours of my heart going that fast.  they gave me a liter of fluid.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac flutter, Echocardiogram abnormal, Electrocardiogram abnormal, Pulse abnormal, Ventricular extrasystoles
Clinical narrative: I developed pre-ventricular contractions. I was feeling fluttering, and I checked my pulse and noticed long delays. I went to urgent care, and they saw it on an echocardiogram. I have to go for a Z-Patch next week and I have to wear a heart monitor starting October 14, 2022. They also prescribed verapamil and stopped to Topromil. The symptoms have improved. I do feel better with the medication, but I am not completely recovered.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent Pfizer administered on accident instead of bivalent Pfizer
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received last booster dose less than 2 months ago
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Patient's arm began to swell and redden outward from the injection site. Patient presented to her PCP who said it was an allergic reaction and patient should take Benadryl to help alleviate the symptoms. Patient reported back to vaccination site on 10/7 to report allergic reaction and to report that the reaction was getting better/resolving.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received the Pfizer BioBTech Bivalent booster before completing primary series. This was her first and only COVID-19 vaccination. Patient experienced no symptoms after receiving the bivalent booster.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given the wrong vaccine - was supposed to receive the 6 month- 4 year vaccine, and received the 5-11 covid vaccine.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent Pfizer administered on accident instead of bivalent Pfizer
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent Pfizer administered on accident instead of bivalent Pfizer
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent Pfizer administered on accident instead of bivalent Pfizer
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Monovalent Pfizer administered on accident instead of bivalent Pfizer
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Oropharyngeal pain, Pain, SARS-CoV-2 test negative
Clinical narrative: I have a sore throat, cough, and body aches. I am taking an antibiotic, cough medicine, and Advil.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given Pfizer COVID Bivalent 12+ instead of the Pfizer 5-11yr, patient showed no reaction or illness after the fact.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: After administering vaccine, patient stated he had already received a flu shot this year.   No side effects or issues identified at the vaccination site.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent Pfizer administered on accident instead of bivalent Pfizer
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vibratory sense increased
Clinical narrative: We got the vaccine early in the morning. By noon, I was really tired, so I took a nap on the couch. I woke up because my entire body was vibrating. It lasted on and off for a little over a month. The fatigue went away the day after the shot.
Age: 18.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Loss of consciousness, Musculoskeletal disorder, Pallor
Clinical narrative: Patient was sitting in the chair and a minute or two after administering both vaccines he slouched over and passed out.  He had a difficult time coming around and he was pale and white.  The ambulance was called and patient was taken to the hospital to be checked out.  He was OK and coherent by time the ambulance came.
Age: 35.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Herpes zoster, Rash
Clinical narrative: I developed shingles just a couple of days after receiving the two vaccines (diagnosed by my primary care doctor 2 days after rash started). My shingles covers my entire left arm (the arm I received the Covid booster in).  While I know it is not likely that the vaccine caused the shingles, it seems like maybe both vaccines at once (along with being a new parent and being sleep deprived) was just too much for my immune system to keep shingles from occurring. I was started on VALACYCLOVIR HCL 1 GRAM  3x per day for 7 days. My doctor expects a routine course of shingles with full recovery in a few weeks.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Feeling abnormal, SARS-CoV-2 test positive
Clinical narrative: I woke up on August 29, 2022, not feeling good. I had not felt like this for years. I took a home COVID-19 test and it came back negative, took a generic Naproxen and went to work. While I was at work a friend who had spent the went the weekend called and to let me know that he had tested positive for COVID-19. I went home immediately and tested again, my results came back positive. I called my doctor's office but they were closed and I was advised from the afterhours service to to go to Urgent Care. She retested me, it came back positive, advised me to increase my Vitamin D, Tylenol,  gave me a prescription for Paxlovid, that I started that night. I did get rebound COVID-19. I do still have a small cough.
Age: 64.0
Sex: M
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PT WAS GIVEN A HIGH DOSE FLUAD AT AGE 64 AND SHOULD HAVE BEEN GIVEN A STANDARD QUADRIVALENT VACCINE
Age: 47.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Headache, Migraine, Musculoskeletal pain, Musculoskeletal stiffness, Nausea
Clinical narrative: Extreme migraine began within 2 hours of injection, followed by neck stiffness with pain radiating down right scapula, and nausea.  As of this entry the headache/neck pain has been ongoing for 7 days and has not lessened with multiple uses of:  heat, rest, lidocane patch, Ibuprofen, Tylenol, Immitrex, Valium, or  intramuscular Toradol injections.  The nausea subsided after 5 days, but now there is an aversion to eating.
Age: 47.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Neck pain, Pain
Clinical narrative: Extreme migraine began within 2 hours of injection, followed by neck stiffness with pain radiating down right scapula, and nausea.  As of this entry the headache/neck pain has been ongoing for 7 days and has not lessened with multiple uses of:  heat, rest, lidocane patch, Ibuprofen, Tylenol, Immitrex, Valium, or  intramuscular Toradol injections.  The nausea subsided after 5 days, but now there is an aversion to eating.
Age: 47.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Computerised tomogram, Condition aggravated, Dizziness, Fatigue, Headache
Clinical narrative: Extreme migraine began within 2 hours of injection, followed by neck stiffness with pain radiating down right scapula, and nausea.  As of this entry the headache/neck pain has been ongoing for 7 days and has not lessened with multiple uses of:  heat, rest, lidocane patch, Ibuprofen, Tylenol, Immitrex, Valium, or  intramuscular Toradol injections.  The nausea subsided after 5 days, but now there is an aversion to eating.
Age: 47.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Laboratory test, Loss of personal independence in daily activities, Malaise, Migraine, Musculoskeletal stiffness
Clinical narrative: Extreme migraine began within 2 hours of injection, followed by neck stiffness with pain radiating down right scapula, and nausea.  As of this entry the headache/neck pain has been ongoing for 7 days and has not lessened with multiple uses of:  heat, rest, lidocane patch, Ibuprofen, Tylenol, Immitrex, Valium, or  intramuscular Toradol injections.  The nausea subsided after 5 days, but now there is an aversion to eating.
Age: 47.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Nausea, Pain, Painful respiration, Sensory disturbance
Clinical narrative: Extreme migraine began within 2 hours of injection, followed by neck stiffness with pain radiating down right scapula, and nausea.  As of this entry the headache/neck pain has been ongoing for 7 days and has not lessened with multiple uses of:  heat, rest, lidocane patch, Ibuprofen, Tylenol, Immitrex, Valium, or  intramuscular Toradol injections.  The nausea subsided after 5 days, but now there is an aversion to eating.
Age: 10.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: Dad asked for flu shot and second covid 19 vaccine to be given at office visit. We were not aware that mom had them vaccinated with second vaccine at an outside facility in August.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature abnormal, Delusion, Disorientation, Eye disorder, Tremor
Clinical narrative: Starting that evening, patient began being delusional. "He was making up a bed for his grandson to stay over,". He lost orientation to person & place (wife did not ask about time when occuring). His eyes were "glazed over," his arm was shaking, and he had a temperature.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Needle issue
Clinical narrative: Patient was receiving Gardasil vaccine in office. Vaccine given, when the nurse withdrew the vaccine the needle detached and remained in the patients arm. The nurse was able to remove the needle without harm to patient or herself.   Needle used: BD SafetyGlide Needle 25Gx5/8 Ref 305901. Lot 1343388 exp 11/30/2026
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Dad asked for flu shot and second covid 19 vaccine to be given at office visit. We were not aware that mom had them vaccinated with second vaccine at an outside facility in August.
Age: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flublok given to pt <18 . No adverse events
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent Pfizer administered on accident instead of bivalent Pfizer
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent Pfizer administered on accident instead of bivalent Pfizer
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent Pfizer administered on accident instead of bivalent Pfizer
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered expired
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: pt reported she had the rash around the injection site , the rash last for 1 week then gone
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Several months after the vaccine was administered, I had fatigue, headache, major sore throat, slight feverish. I took a COVID-19 home test on 7/23/22 and the results were positive. I was traveling and I called a provider and was prescribed Paxlovid. It took me about 8 days to recover.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Several months after the vaccine was administered, I had fatigue, headache, major sore throat, slight feverish. I took a COVID-19 home test on 7/23/22 and the results were positive. I was traveling and I called a provider and was prescribed Paxlovid. It took me about 8 days to recover.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fluid intake reduced, Hypophagia, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: 1st 24 hours nausea, couldn't eat or drink, muscle aches; swelling of right bicep, rash, itchy, hot spread all the way to elbow lasted about 8 days
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Nausea
Clinical narrative: 1st 24 hours nausea, couldn't eat or drink, muscle aches; swelling of right bicep, rash, itchy, hot spread all the way to elbow lasted about 8 days
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent Pfizer administered on accident instead of bivalent Pfizer
Age: 38.0
Sex: F
Vaccine: VARZOS
Symptoms: Anticoagulant therapy, Massage, Nodule, Venous thrombosis limb
Clinical narrative: palmar digital vein thrombosis of around 2mm in size appeared on my right middle finger at the lower joint, on the left side of the finger. thrombosis appeared on Tuesday, October 4th in the evening, and has continued for 5 days so far. I've attempted to manage it with massage, hot compresses, and asprin but it hasn't gotten any smaller.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. HBP provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report was received from a Healthcare Business Professional and refers to a patient of an unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 06-SEP-2022, thepatient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1879864, expiration date: 19-OCT-2023) (strength, and route of administration were not provided) for prophylaxis. No adverse events were reported. According to the reporter, the temperature excursion was above 46 (62.8) degrees Fahrenheit for a time frame of 8 hours on 05-SEP-2022, without any previous temperature excursion.; Sender's Comments:  US-009507513-2209USA002722:02242096 US-009507513-2209USA002532:02242096 US-009507513-2209USA002779:
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: had Covid-19; This spontaneous report was received from a retired dentist who was reporting on himself as a male patient of an unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date (reported as "just before Covid happened"), the patient was vaccinated with one dose of  zoster vaccine live (ZOSTAVAX) (strength, lot #, expiry date, and route of administration were not provided) for prophylaxis. On an unknown date, the patient had Covid-19.  On an unknown date, the patient recovered from the event. The causal relationship between had Covid-19 and zoster vaccine live (ZOSTAVAX) was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD was administered after a temperature excursion; This spontaneous report was received from a Medical Assistant and refers to a patient of an unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 01-SEP-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #W006585, expiration date: 23-AUG-2023) (strength, and route of administration were not provided) for prophylaxis. No adverse events were reported. According to the reporter, the temperature excursion was 1.6 degrees Celsius for a time frame of 2 hours 10 minutes on an unknown date, without any previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; VARIVAX was administered after a temperature excursion; This spontaneous report was received from an other health professional and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions were and concomitant therapies were not reported.  On 31-AUG-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U020240, expiration date: 28-JUN-2023 (both confirmed to be valid) administered for prophylaxis (strength, and route of administration were not provided) (product storage error). The vaccine underwent a temperature excursion of 5.7 degree Fahrenheit for 0 hours 30 minutes and 0 seconds. There was previous temperature excursion of 6 degree Fahrenheit up to 14 degree Fahrenheit (9.1 degree Fahrenheit) for 1 hour 6 minutes and 0 seconds . No additional adverse event reported (no adverse event), no further information provided.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient received their first dose of GARDASIL 9 in OCT2019 when she was 17 but never received her second or third doses. The patient was in the pharmacy today 9SEP2022 to receive her next dose of GARDSIL 9; No additional AE details were provided; This spontaneous report was received from a pharmacist and refers to a female patient . The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in October 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (strength, lot #, and expiry date were not provided) administered intramuscularly for prophylaxis.The patient never received her second or third doses (inappropriate schedule of product administered). There were no additional adverse events details provided (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; HBP responsible for vaccines reported a dose of PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 24-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #W017570, expiration date: 29-NOV-2023, administered for prophylaxis (dose, strength, site, and route of administration were not provided) after a temperature excursion (product use issue). The temperature: 5.7F, time frame: 0 Hours 30 Minutes and 0 Seconds. The previous temperature excursion: 6 degrees Fahrenheit (F) up to 14 degrees F (9.1F) for 1 Hour 6 Minutes and 0 Seconds. No additional adverse events details or product quality complaints were reported (no adverse event).
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs reported.; Caller is an nurse reporting an AE on behalf of a consumer. The caller stated that expired GARDASIL 9 was administered to a patient on (25-MAY-2022). The caller noted that this was within thirty days of the GARDASIL 9's expiration date. Permission t; This spontaneous report was received from a nurse and refers to an 18-year-old female patient.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 25-MAY-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #T007035, expiration date: 01-MAY-2022, administered for prophylaxis (dose, strength, site, and route of administration were not provided) (expired product administered). No additional adverse events details or product quality complaints were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; a dose of PROQUAD was administered after a temperature excursion; This spontaneous report was received from a health bussiness professional (HBP) responsible for vaccines and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 19-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # W017570, expiration date 29-NOV-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis. The suspect vaccine was improperly stored at a temperature of 5.7 Fahrenheit (F) for 30 minutes. The vaccine was previously improperly stored at a temperature of 6 F up to 14 F for 1 hour 6 minutes and at a temperature of 6 F up to 14 F for 1 hour and 8 minutes. No adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Rubber sensitivity
Clinical narrative: Caller did not confirm, following previous 09/2021 MMRII administration, if Patient had presented with allergic reaction to latex with, at current call time, Caller confirming how corresponding Patie; This spontaneous report has been received from a registered nurse referring a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies and concomitant medications were not provided. Patient's current condition included allegic to latex.  On an unspecified date in September 2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin(rHA)) (M-M-R II) subcutaneous injection (strength, dose, frequency, route of administration, site of vaccination, and expiration date was not provided; lot number T000890 had been verified to be a valid number; expiration date established as 08-JAN-2022) for prophylaxis.  On an unknown date, the patient experienced allergic reaction to latex (latex allergy). The outcome of the event was not provided. Patient's series vaccination was interrupted and the patient missed a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the event latex allergy was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no additional adverse event; VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a physician concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 21-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W017552, expiration date: 01-JUN-2024, administered as prophylaxis (strength, and route of administration were not provided).  It was reported that the vaccine was administered after a temperature excursion at a temperature of 28.2 Fahrenheit degrees for 1 hour (product storage error). No previous temperature excursion or additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AEs; Caller reported VARIVAX administered after expiration date; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 27-SEP-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, administered subcutaneous, lot # T032322, expiration date 22-SEP-2022 (expired product administered). No additional events were reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-SEP-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #u024221, expiration date: 04-AUG-2023, administered for prophylaxis (dose, strength, and route of administration were not provided) (Product storage error).  Administered dose of vaccine experienced the temperature excursion of -12.5 degrees Celsius (C) for 1 hour. There was no previous temperature excursion.  There was no adverse event reported (No adverse event).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around September 2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations and seriousness of his condition. As a result of the zoster vaccine live (ZOSTAVAX), he sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered to be not recovered. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of shingles was determined to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient (pt) suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations and seriousness of the pt's condition. As a result of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered to be not recovered. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of shingles was determined to be disabling.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event (AE); A pediatric dose of VAQTA with a labeled expiry of 10/1/2022 was administered to a patient on 10/3/2022.; This spontaneous report was received from a nurse and refers to a unknown age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 03-0CT-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) at a dose of 0.5 mililiter (ml), lot number 1792241, expiration date: 01-OCT-2022, who had been verified to be a valid number, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; an improperly stored vaccine was administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, allergies and drug reactions were not provided.   On 16-SEP-2022, the patient was vaccinated with improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U039726, expiration date: 15-DEC-2023, (strength, dose, dose number, route and site of vaccination were not provided) for prophylaxis (product storage error). The suspect vaccine underwent temperature excursion of -11.8 Celsius degrees (C) for 1 hour and 45 minutes. The previous temperature excursion was not reported. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No additional AE; an improperly stored vaccine was administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, allergies and drug reactions were not provided.   On 16-SEP-2022, the patient was vaccinated with improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U039726, expiration date: 15-DEC-2023, (strength, dose, dose number, route and site of vaccination were not provided) for prophylaxis (product storage error). The suspect vaccine underwent temperature excursion of -11.8 Celsius degrees (C) for 1 hour and 45 minutes. The previous temperature excursion was not reported. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a nurse referring to a 12-month-old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.   On 16-SEP-2022, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) quantity 1, lot # U039726, expiration date: 15-DEC-2023, administered for prophylaxis (strength, route of administration, vaccination scheme frequency, anatomical location, and dose were not reported) after a temperature excursion (temperature: -11.8 degrees Celsius (C); time frame: 1 hour 45 minutes) (product storage error). There was previous temperature excursion (details not reported). No additional adverse event was reported (no adverse event).  This is one of 17 reports received from the same reporter.
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: no adverse event; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a nurse referring to a 12-month-old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.   On 16-SEP-2022, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) quantity 1, lot # U039726, expiration date: 15-DEC-2023, administered for prophylaxis (strength, route of administration, vaccination scheme frequency, anatomical location, and dose were not reported) after a temperature excursion (temperature: -11.8 degrees Celsius (C); time frame: 1 hour 45 minutes) (product storage error). There was previous temperature excursion (details not reported). No additional adverse event was reported (no adverse event).  This is one of 17 reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE.; HCP reporting an improperly stored vaccine was administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-SEP-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot # W019623, expiration date 19-DEC-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced temperature excursion of -12.5 degrees Celsius for 1 hour and 45 minutes (product storage error, temperature too high). There were no previous excursions reported. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; improperly stored vaccine was administered to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-SEP-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (PROQUAD) subcutaneous injection, lot #W019623, expiration date: 19-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). Administered dose of vaccine experienced the temperature excursion of -11.8 Celsius degree for 1 hour 45 minutes. No previous temperature excursion was reported. No additional details were provided. No additional adverse event or product quality complaint was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP reporting an improperly stored vaccine was administered to a patient. No additional details provided. No additional AE. No PQC.   ?    Names of vaccines involved: PROQUAD (Lot: W017567, Expiration Date: 29DEC2023) ?    Temperature: -11.8C ?; This spontaneous report was received from the registered nurse and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 26-SEP-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #W017567, expiration date: 29-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided).  The vaccine was improperly stored (temperature: -11.8 Celsius degrees, time frame: 1 hour 45 minutes). No additional details, nor adverse events were provided.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE.; an improperly stored vaccine was administered to a patient.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 13-SEP-2022, the patient was vaccinated with an improperly stored (temperature: -11.8 Celsius [C] degrees, time frame: 1 hour, 45 minutes, 0 seconds) measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot #W019623 was found to be valid, expiration date: 19-DEC-2023 (strength, dose, route of administration and vaccination site were not reported) for prophylaxis (product storage error). No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; improperly stored vaccine was administered to a patient.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 19-SEP-2022, the patient was vaccinated with an improperly stored (temperature: -11.8 Celsius [C] degrees, time frame: 1 hour, 45 minutes, 0 seconds) measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot #W019623 was found to be valid, expiration date: 19-DEC-2023 (strength, dose, route of administration and vaccination site were not reported) for prophylaxis (product storage error). No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; Patient received improperly stored vaccine; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 03-OCT-2022, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot number 1879866 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and confirmed as 30-OCT-2023) (exact dose was not provided) administered orally as prophylaxis. The vaccine administered suffered a temperature excursion of 55.8 Farenheit (C) degrees for a time frame of 44 hours (Product storage error), and did not suffered previous temperature excursions.  No additional adverse events (AEs) were reported. No further information provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored vaccine was administered to a patient; This spontaneous report was received from a nurse referring to 12-month-old patient of unknown gender. Relevant medical history, drug reactions/allergies and concomitant medication for the patient involved was not reported.  On 13-SEP-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number: W002601 (expiration date: 24-JAN-2024) for prophylaxis (strength, route, dose or units were not provided).   The storage characteristics were the following: Temperature: -11.8C Time frame: 1 Hour 45 Minutes 0 Seconds Previous temperature excursion?: No  No adverse effects were reported.