chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discomfort, Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: Approximately seven hours after receiving my Moderna vaccination I started feeling extreme pain in my left shoulder.  My shoulder was throbbing I could not lift my hand above my head without extreme pain.  It continued through the night, I delayed going to bed because of the pain after laying down for 15 minutes I got up because I could not do anything without having serious pain.  I went back to bed in a hour later and had the same result and got up and did not go to bed that night.  It did not matter what position I was in, and the throbbing continued and left me extremely uncomfortable.  In the morning I started to research shoulder pain related to vaccinations and I came across SIRVA.   What I read reference SIRVA was exactly what was happening to me I had very limited range of motion in my shoulder and could barely move my arm without extreme pain. Tylenol and Ibuprofen did not help.     I called the nurse help line in the afternoon and it was suggested I go to the ER.  I visited the ER in the afternoon.  The two nurses that saw my arm and where the Band-Aid was place thought that was awful high entry point for a vaccination.  The two nurses and the doctor I spoke to had not heard of SIRVA.  I explained what happened, but long story short is I was given medication one narcotic,  some extra strength ibuprofen and muscle relaxer. I was given a prescription for muscle relaxer and ibuprofen and sent on my way.    I continue to have pain and reduced mobility in my shoulder/arm.
Age: 63.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Client received Prevnar 20 vaccination on 06/08/22, data base was not updated, and client was given a second dose of Prevnar 20 on 10/28/22.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient expired 11/4/2022.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Body temperature increased, Pain, Somnolence
Clinical narrative: After vaccine started to feel weak, achy, had a temper and my body hurt really bad. Slept a long time, and continued to feel weak. Would have gone to the ER but I didn't have anyone to take me. Called my doctor because the pain was so bad, advised me to take my regular pain medication and rest. One week later I started feeling a little better.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Patient experienced mild urticaria and pruritis at injection site within a minute of vaccine delivery.  Patient was monitored for 10 minutes before guardian had to leave clinic to attend to an emergency.  Patient was given 25mg of Benadryl for the pruritis.  No other symptoms observed.  Signs and symptoms of anaphylaxis provided.
Age: 65.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Extra dose administered
Clinical narrative: Client received Prevnar 20 vaccination on 6/8/22, data base was not updated, and client was given a second dose of Prevnar 20 on 11/1/22.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: left shoulder pain with overhead activity, painful range of movement, no signs of infection, mild symptoms improving but not going away  PT referral, orthopedics sport medicine referral, sulindac 200 mg tab, prednisone 20 mg tab
Age: 35.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Client received Prevnar 20 vaccination on 6/8/22, data base was not updated, and client was given a second dose of Prevnar 20 on 10/27/22.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Cough, Diarrhoea, Feeling abnormal, Influenza
Clinical narrative: After 5 hours from receiving the vaccine, I came down with the flu.  Fever, muscle aches, head fog, coughing, sneezing and weakness. Took Advil and Oseltamivir Phosphate (had to stop - diarrhea).
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza virus test positive, Myalgia, Pyrexia, Sneezing
Clinical narrative: After 5 hours from receiving the vaccine, I came down with the flu.  Fever, muscle aches, head fog, coughing, sneezing and weakness. Took Advil and Oseltamivir Phosphate (had to stop - diarrhea).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Myocarditis
Clinical narrative: myocarditis; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) and COVID-19 (COVID-19) outcome was unknown.            Concomitant medication was not provided.  On 31-AUG-2022 patient had COVID-19, it was simple, did not have much symptoms.  Treatment medication was not provided.  Company comment- This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced expected, serious (medically significant) AESI Myocarditis, which occurred at an unknown time with regards to vaccination with a third dose mRNA-1273. No further information was reported. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced expected, serious (medically significant) AESI Myocarditis, which occurred at an unknown time with regards to vaccination with a third dose mRNA-1273. No further information was reported. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Your vaccine killed my son.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 22-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Your vaccine killed my son.". Your vaccine killed him my healthy 22yrs old son. He was gone because of your vaccine. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Your vaccine killed my son.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.   On 06-OCT-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (rHA) subcutaneous injection, (lot number W017574, expiration date 29-NOV-2023) (strength, dose, route of administration and anatomical location were not provided) as prophylaxis (product storage error). Temperature was 10.8 fahrenheit (F) for time frame 1 hour and 39 minutes. There was no previous temperature excursion. No additional adverse event details were provided (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA002259: US-009507513-2210USA002344: US-009507513-2210USA002172: US-009507513-2210USA002083: US-009507513-2210USA002276:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; Healthcare provider is reporting administration of an expired dose of ROTATEQ [1742415, 10/12/2022] on 17OCT2022; This spontaneous report was received from a medical assistant and refers to a 4-month-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reaction or allergies, and concomitant therapies were not reported.  On 17-OCT-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot #1742415 with expiration date 12-OCT-2022, for prophylaxis (dosage was not reported). The vaccine was not involved in a temperature excursion. No additional adverse events (AES) reported. No further information was provided.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE reported. No PQC reported. No additional information provided.; Customer called and reported that a 10 month old was administered a GARDASIL-9 vaccine today, 24OCT2022. The 10 month old was supposed to be receiving a flue shot; however, GARDASIL-9 was inadvertently administered instead.; Customer called and reported that a 10 month old was administered a GARDASIL-9 vaccine today, 24OCT2022. The 10 month old was supposed to be receiving a flue shot; however, GARDASIL-9 was inadvertently administered instead.; This spontaneous report was received from am medical assistant concerning a 10-month-old male patient. His concomitant therapies, pertinent medical history, and drug reactions/allergies were not reported.  On 24-OCT-2022, the patient was supposed to receive a flu shot. However, he was inadvertently administered with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection instead (strength, dose, route of administration were not reported; lot#: U037064, expiration date: 10-AUG-2024) for prophylaxis (product administered to patient of inappropriate age; wrong product administered). No additional adverse event (AE) was reported.
Age: 0.83
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional information provided. No additional AE reported. No PQC reported.; Caller is a nurse calling to report that a dose of GARDASIL 9 was inadvertently administered to a 10-month old patient.; This spontaneous report was received from a licensed practical nurse concerning a 10-month-old patient of unknown gender. The patient's concomitant therapies, pertinent medical history, and drug reactions/allergies were not reported.  On 24-OCT-2022, the patient was inadvertently administered with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) was reported. No additional information was provided.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; improperly stored dose of were administered to a patient on 24 OCT 2022; This spontaneous report was received from the vaccine coordinator, and refers to a 12-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 24-OCT-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #U034522, expiration date: 22-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; GARDASIL 9 was administered to one patient after a temperature excursion; This spontaneous report was received from the Nurse Prescriber and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 28-OCT-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1775827, expiration date: 27-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was administered after a temperature excursion (product storage error). No additional adverse event was provided.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pt was given Pfizer bivalent booster 0.3mL(age12 and above), pt is 9 yr and 9mos old.  Will follow-up with pt regarding adverse events
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Child administered 0.5ml Afluria PFS (recommended for 3+ years) - child tolerated dose well, waited in clinic 20 minutes after vaccine administered with no reaction; vaccine administered at 1:36pm, mother contacted at 3:45pm of incorrect dose administered and child still tolerating well
Age: 0.58
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: No reactions to vaccines. Moderna vaccine was expired by 3 days.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue
Clinical narrative: Extreme fatigue. Started today
Age: 17.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Incorrect dose administered
Clinical narrative: The patient is a minor and has a history of Keloid Scarring. The patient was administered the monkeypox Jynneos vaccine intradermal of 0.1 mL, instead of receiving the CDC guidelines for individuals younger than 18 years of age which is 0.5 mL dosage with route of subcutaneous.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Myocardial infarction
Clinical narrative: light headed ness and dizziness lack of appetite
Age: 43.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Allergy test, Erythema, Pruritus, Sensitive skin, Sensory disturbance
Clinical narrative: I experienced few days later I stated getting very itchy skin, all over my body. I would occasionally have hives usually on my neck and face and sometimes in my shoulders. When I would scratch myself I would develop red whelps. My eyelids felt weird and bit swollen and also felt my blood was having like an allergic reaction. I went to see my allergist and the did a series of allergy tests but the results were invalid because my skin was hypersensitive. I continue with my symptoms today. My doctor also recommended an antihistamine (ALLEGRA medication) four times a day but now I am down taking it two times a day. I do have a follow up appointment with my allergist on 11/11/2022. I also have never had a reaction like this before along with taking a flu shot vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Swelling of eyelid, Urticaria
Clinical narrative: I experienced few days later I stated getting very itchy skin, all over my body. I would occasionally have hives usually on my neck and face and sometimes in my shoulders. When I would scratch myself I would develop red whelps. My eyelids felt weird and bit swollen and also felt my blood was having like an allergic reaction. I went to see my allergist and the did a series of allergy tests but the results were invalid because my skin was hypersensitive. I continue with my symptoms today. My doctor also recommended an antihistamine (ALLEGRA medication) four times a day but now I am down taking it two times a day. I do have a follow up appointment with my allergist on 11/11/2022. I also have never had a reaction like this before along with taking a flu shot vaccine.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none to any vaccine
Age: 17.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect dose administered, Incorrect route of product administration, Underdose
Clinical narrative: The patient was administered the monkeypox Jynneos vaccine intradermal of 0.1 mL, instead of receiving the CDC guidelines for individuals younger than 18 years of age which is 0.5 mL dosage with route of subcutaneous.
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered, Vaccination error
Clinical narrative: This is the reporting of a vaccination error and not an adverse event that occurred.  Situation: Patient was administered the Fluad Quadrivalent flu vaccine on 11/02/2022, but he had already received the same Fluad Quadrivalent flu vaccine earlier on 10/27/2022.  As the patient received two doses of Fluad Quadrivalent flu vaccine within the same 2022-2023 flu season in error, what are the possible risks/side effects should we look out for? Since patient also received several other vaccines (Shingrix, Pneumovax 23) within one week prior to receiving the second dose of Fluad Quadrivalent flu vaccine, would this second dose of flu vaccine interact with the efficacy of those vaccines, and/or result in greater risk of adverse events?
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The client was given a Pfizer 12 year and up vaccine instead of Pedi Pfizer 5-11 years old.  No adverse symptoms. Mom made aware: the child was still in clinic waiting the 15 minutes after the vaccine.
Age: 38.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient came in for a Pfizer Covid Booster, but the pharmacy gave Flublok instead. However, the patient hasn't gotten Flu shot for the year 2022. So the patient got both shots today 11-4-22 FluBlok and Pfizer Bivalent Booster. No reaction has been seen yet.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: On 10/31/2022 patient was given Monovalent Pfizer vaccine Instead of Pfizer bivalent.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling
Clinical narrative: Severe arm swelling
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Asthma, Chest discomfort, Chest pain, Chiropractic
Clinical narrative: That very same evening, I was extraordinarily weak and achy. I did go to bed early and woke a couple hours into sleeping and had a fever of 103. It was so bad, I got ice packs, drink water and took TYLENOL. I went to my chiropractor, because my lymph nodes were really swollen. I was sick with a serious fever. Under my arm it was so swollen I could barely put my arm down. I have been waiting to see if it will go away, but I still feel a debilitating fatigue and I feel my chest is heavy. It's aggravating my asthma. The lymph node is still swollen but it's not as huge as it was yesterday. The swelling has gone down today. This is the left arm.  The pain went through to my shoulder blade and all the way up my neck, shoulder blade and chest. It's all still really sore.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Fatigue, Lymphadenopathy, Malaise, Musculoskeletal pain
Clinical narrative: That very same evening, I was extraordinarily weak and achy. I did go to bed early and woke a couple hours into sleeping and had a fever of 103. It was so bad, I got ice packs, drink water and took TYLENOL. I went to my chiropractor, because my lymph nodes were really swollen. I was sick with a serious fever. Under my arm it was so swollen I could barely put my arm down. I have been waiting to see if it will go away, but I still feel a debilitating fatigue and I feel my chest is heavy. It's aggravating my asthma. The lymph node is still swollen but it's not as huge as it was yesterday. The swelling has gone down today. This is the left arm.  The pain went through to my shoulder blade and all the way up my neck, shoulder blade and chest. It's all still really sore.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neck pain, Pain, Pyrexia, Sleep disorder
Clinical narrative: That very same evening, I was extraordinarily weak and achy. I did go to bed early and woke a couple hours into sleeping and had a fever of 103. It was so bad, I got ice packs, drink water and took TYLENOL. I went to my chiropractor, because my lymph nodes were really swollen. I was sick with a serious fever. Under my arm it was so swollen I could barely put my arm down. I have been waiting to see if it will go away, but I still feel a debilitating fatigue and I feel my chest is heavy. It's aggravating my asthma. The lymph node is still swollen but it's not as huge as it was yesterday. The swelling has gone down today. This is the left arm.  The pain went through to my shoulder blade and all the way up my neck, shoulder blade and chest. It's all still really sore.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test abnormal, Carcinoembryonic antigen increased, Colectomy, Colonoscopy abnormal, Computerised tomogram normal
Clinical narrative: Routine colonoscopy screening on 05/ 26/2022 showed a 18 mm recto-sigmoid polyp  invasive carcinoma.  Subsequent resection 07/21/2022 partial colectomy showed no evidence of residual cancer
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Large intestine polyp, Neoplasm malignant, Scan with contrast normal
Clinical narrative: Routine colonoscopy screening on 05/ 26/2022 showed a 18 mm recto-sigmoid polyp  invasive carcinoma.  Subsequent resection 07/21/2022 partial colectomy showed no evidence of residual cancer
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: It was discovered that bivalent dose given less than 2 months since last booster dose. No adverse reactions reported at this time.
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident
Clinical narrative: Patient got covid pfizer bivalent booster on 10/7/22. On 10/9/22 she suffered a massive stroke.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient is 7 years old. In database, his first dose of COVID vaccine is documented as the Pfizer SARS-COV 2 Peds 6 mo-4 years, given 9/8/22. He received the correct dose for his age on 10/5/22.  Nursing alerted me to this discrepancy while patient was in office today for an ADHD visit, which was just identified today. I disclosed to mom that patient appeared to be underdosed for his first COVID vaccine or this could be a clerical error on our side. I apologized and stated that no harm was caused to her son, but we do need to make a plan forward. MOC stated she had his COVID vaccine card at home - advised nursing leadership would call tomorrow to f/u and confirm which vaccine was given 9/8/22.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Breast cancer female, Condition aggravated
Clinical narrative: Pt stated she bled for a bit afterwards, 2 months Hep C reactivated,  In August 2021 started having palpitations, and was then diagnosed with Breast cancer.  Pt feels this needs to reported.  She has been seen multiple times since the incident and has never reported this.  There is no documentation about the bleeding at the time of the injection either.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Haemorrhage, Hepatitis C, Mitral valve prolapse, Palpitations
Clinical narrative: Pt stated she bled for a bit afterwards, 2 months Hep C reactivated,  In August 2021 started having palpitations, and was then diagnosed with Breast cancer.  Pt feels this needs to reported.  She has been seen multiple times since the incident and has never reported this.  There is no documentation about the bleeding at the time of the injection either.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tricuspid valve incompetence
Clinical narrative: Pt stated she bled for a bit afterwards, 2 months Hep C reactivated,  In August 2021 started having palpitations, and was then diagnosed with Breast cancer.  Pt feels this needs to reported.  She has been seen multiple times since the incident and has never reported this.  There is no documentation about the bleeding at the time of the injection either.
Age: 7.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pharmacist was reviewing vaccines given earlier in the day when she noticed the pediatric bivalent booster was not opened but kids under the age of 12 came in earlier in the day. The pharmacist asked the pharmacy intern that was administering vaccines and she realized that she gave the wrong dose to the child (an adult pfizer booster was given instead of pediatric). Patient was asked to monitor for symptoms and the doctor was reached out to. They do not see any major side effects occurring for the patient.
Age: 7.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLUC4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pharmacist was reviewing vaccines given earlier in the day when she noticed the pediatric bivalent booster was not opened but kids under the age of 12 came in earlier in the day. The pharmacist asked the pharmacy intern that was administering vaccines and she realized that she gave the wrong dose to the child (an adult pfizer booster was given instead of pediatric). Patient was asked to monitor for symptoms and the doctor was reached out to. They do not see any major side effects occurring for the patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Peripheral swelling, Rash, Skin warm, Urticaria
Clinical narrative: Left arm, rash, swelling/welts and warm to touch.   No treatment  Area was inflamed for several days.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: On 10/31/2022 the patient was given Pfizer Monovalent instead of Bivalent
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pt received a Bivalent Pfizer Booter 12+ dose which was a higher than recommended dose as she should have received a bivalent 5-11 dose.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pharmacist was reviewing vaccines given earlier in the day when she noticed the pediatric bivalent booster was not opened but kids under the age of 12 came in earlier in the day. The pharmacist asked the pharmacy intern that was administering vaccines and she realized that she gave the wrong dose to the child (an adult pfizer booster was given instead of pediatric). Patient was asked to monitor for symptoms and the doctor was reached out to. They do not see any major side effects occurring for the patient. No adverse event reported for the patient.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus still ongoing
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Eczema, Urticaria
Clinical narrative: Patient also reported having hives and eczema all over the body after her second dose of the Pfizer Covid-19 vaccine in April 2021 three days after injection which resulted in neck, face, and whole-body hives which took 10 days of prednisone to clear but then afterward she started having severe eczema which she had not ever had before and still continues to be an issue. Patient reported having bad hives again in her arms when she was infected with Covid-19 in July 2022. Again, she had to be on oral steroid for 7 to 10 days for the hives to resolve.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pharmacist was reviewing vaccines given earlier in the day when she noticed the pediatric bivalent booster was not opened but kids under the age of 12 came in earlier in the day. The pharmacist asked the pharmacy intern that was administering vaccines and she realized that she gave the wrong dose to the child (an adult pfizer booster was given instead of pediatric). Patient was asked to monitor for symptoms and the doctor was reached out to. They do not see any major side effects occurring for the patient. No adverse event reported for the patient.
Age: 1.17
Sex: M
Vaccine: HEP, UNK, UNK
Symptoms: Extra dose administered
Clinical narrative: Advised mother of the administered dose one of Pediarix and administered 2nd dose of Hep-B instead of just Pediarix.  Unauthorized age group: Patient received 10 mcg/0.5ml Hep-B in left leg.  Vaccine administered by employee.  The director of nursing spoke with the patients mother on 11/4/2022 @ 5:40p. The mother denies the patient has/had any adverse event(s) from the vaccine.   The mother states:"he is his normal self. So far so good."  Explained to the mother to report any problems, PCP and to take patient to the emergercy room with any adverse affects.   Answered all questions and gave mother Directors contact information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Blood test, COVID-19, Condition aggravated, Depression
Clinical narrative: I had already been diagnosed with depression in 2021 after my COVID-19 infection. But in early 2022 after my first booster, I began experiencing suicidal ideation. After my infection in December 2020, I was subsequently diagnosed with depression anxiety. As the months continued and I received the vaccines and the booster, my depression worsened. I have experienced a memory loss that began after dose 3. I have seen the neurologist regarding my memory, and I was scheduled to have a memory test. But I no longer live in that city. I have also experienced a severe case of COVID-19 fog.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram, Feeling abnormal, Magnetic resonance imaging, Suicidal ideation, Urine analysis
Clinical narrative: I had already been diagnosed with depression in 2021 after my COVID-19 infection. But in early 2022 after my first booster, I began experiencing suicidal ideation. After my infection in December 2020, I was subsequently diagnosed with depression anxiety. As the months continued and I received the vaccines and the booster, my depression worsened. I have experienced a memory loss that began after dose 3. I have seen the neurologist regarding my memory, and I was scheduled to have a memory test. But I no longer live in that city. I have also experienced a severe case of COVID-19 fog.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Condition aggravated, Immediate post-injection reaction, Tinnitus
Clinical narrative: My initial vaccines were Pfizer. My first booster was Moderna. After the first Moderna booster, I noticed that I had persistent tinnitus, but thought it was probably a coincidence. Then, after my second Moderna booster, my tinnitus immediately got worse and has not abated.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse effects, pt was given Pfizer monovalent. Newest schedule calls for bivalent instead of monovalent for 3 doses
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: Patient was inadvertently given 0.3ml of undiluted pediatric bivalent pfizer booster rather than adult booster. No adverse events reported. Patient was advised to monitor side effects and report any issues.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: a patient received a dose of GARDASIL 9 past expiration. Admin on 9/14/2022; This spontaneous report as received from a registered nurse, referring to a patient of unknown age and gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-SEP-2022, the patient was vaccinated with a dose (also reported as unknown by reporter) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687291 with expiration date: 11-SEP-2022, route and strength were unknown) for prophylaxis. The suspect vaccine was past expiration (expired product administered). There was no temperature excursion. No other issue or concerns noted.  The case is a non-valid due to lack of the patient's identifiers.  Follow up information has been received from a registered nurse on 31-OCT-2022. Details of patient information, suspect vaccine and event were provided. The patient is a 24-year-old male whose medical history included human immunodeficiency viruses (HIV) positive since 27-MAR-2019. The patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in left deltoid three days past expiration. There was no temperature excursion occur as a result of a reading from digital data logger. The outcome was resolved on an unknown date in 2022. The patient was called and checked on and had no complaints. There was no prescription drug treatment for the experience required. The de-challenge and re-challenge results were both considered as negative (de-challenge reported as did not experienced abate after stopping drug, re-challenge reported as did not reappear after reintroduction). The causality was considered as related (reported as the event attributable to the vaccine).
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; HCP calling to report that MMR II was administered today 10/13/22 past its lot expiration date of 10/08/22 and requesting guidance.; This spontaneous report was received from a nurse and refers to a 12-month-old male patient.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 13-OCT-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) at a dose of 0.5 ml/once, lot #T034392, expiration date: 08-OCT-2022, administered for prophylaxis (route of administration was not provided) (Expired vaccine used). No additional adverse event were reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: RN called to report that 31 year old patient requests 3rd dose of GARDASIL 9 after 2nd dose last received at 17 years old. No further information provided. No additional AEs, no PQCs.; This spontaneous report was received from a register nurse referring to a 31 year old female patient. No information regarding her pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On an unknown date, 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) 0.5 mil, once.  On unspecified date (when the patient was 17 years old), the patient was vaccinated with the second of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mil, once.  Currently, the patient requested the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (31 years old) (inappropriate schedule of product administration).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Confirmed with caller no other AE occurred; The caller said an expired dose was administered on 11/1/2022; This spontaneous report was received from a pharmacist and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-NOV-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)syringe, injection, 1 dose, lot number u010533, expiration date: 29-OCT-2022, administered for prophylaxis (exact dose, strength, and route of administration were not provided) (expired product administered. No other adverse event occurred (no adverse event).
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional adverse event; patient received the first dose of GARDASIL 9 over a year ago, and the second dose window of 12 months has already passed; This spontaneous report was received from a pharmacist and refers to a 12-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (reported as over a year ago), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unspecified day in October 2022, the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the second dose window was already passed (inappropriate schedule of product administration). No further information was provided. No additional adverse event was reported. No product quality complaint was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information provided; PNEUMOVAX 23 vaccine was accidentally administered to a patient after the expiration date; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-NOV-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe, injection, 0.5 ml, lot number U003306, expiration date: 15-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). It was reported that the vaccine was stored appropriately and did not have any temperature excursions. No additional adverse event information was provided (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: vaccine was administered while undergoing a temperature excursion; This spontaneous report was received from an office manager (also reported as customer) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-OCT-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot number W012163, expiration date: 12-APR-2024, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was administered while undergoing a temperature excursion (temperature: -10 Celsius degrees (oC) up to 8 oC, time frame: 35 hours; and 9 oC to 25 oC, time frame: 47 hours); no previous temperature excursion) (product storage error).
Sex: U
Vaccine: SMALLMNK
Symptoms: Monkeypox
Clinical narrative: Monkeypox despite completion of Jynneos vaccination; Case reference number US-BN-2022-004175 is a spontaneous case report initially received on 21-Oct-22 from physician via Bavarian Nordic (reference: BN_2022_02595) and concerns a patient of unknown age or gender.  The patient's medical history and concomitant medications details were not provided.  On an unspecified date, as reported in July, the patient was vaccinated with a first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at a dose reported as 'first full dose', through unknown route of administration, at unknown anatomical location, for unknown indication.  On an unspecified date, as reported in August, the patient was vaccinated with a second dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at a dose reported as 'second microdose', through unknown route of administration, at unknown anatomical location, for unknown indication.  On unspecified date, the patient developed monkeypox despite completion of Jynneos vaccination.  As reported, the patient developed milder symptoms.  At the time of this report, the event outcome was unknown.   The reporter did not provide a seriousness assessment and a causality assessment.  This case is linked with the case US-BN-2022-004174 (same reporter).  No further information was provided.; Reporter's Comments: A patient of unknown age and gender developed monkeypox (patient developed milder symptoms) despite completion of Jynneos vaccination. Monkeypox are unlisted and unexpected according to CCDS v1 and USPI. Vaccination with Jynneos may not protect all recipients and may not result in protection in all cases. The outcome was unknown. The patient's medical history and concomitant medications details were not provided. Causality is therefore assessed as not related to suspect product but to environmental factors. The case is serious due to medical significance.; Sender's Comments: A patient of unknown age and gender developed monkeypox (patient developed milder symptoms) despite completion of Jynneos vaccination. Monkeypox are unlisted and unexpected according to CCDS v1 and USPI. Vaccination with Jynneos may not protect all recipients and may not result in protection in all cases. The outcome was unknown. The patient's medical history and concomitant medications details were not provided. Causality is therefore assessed as not related to suspect product but to environmental factors. The case is serious due to medical significance.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: after the 2nd shot I had shingles/suspected vaccination failure; light case of the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 30-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got his/her shots and guess what, after the second shot, had a light case of the shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Skin burning sensation, Vaccination failure
Clinical narrative: Got my two shots, have had shingles twice/Suspected vaccination failure; have had shingles twiceseveral years ago; Excessive amount of pain; Skin is on fire. Clothes bushing against is excruciating; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and burning sensation. On an unknown date, the outcome of the vaccination failure, pain and burning sensation were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and burning sensation to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 30-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got his/her shots and have had shingles twice several years ago. The patient stated that the shingles cause an excessive amount of pain, like the skin was on fire and any clothes bushing against them was excruciating. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Had shingles and did get the shot/Suspected vaccination failure; Had shingles, did not show a rash; He is very miserable; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles two years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK receipt date: 30-Oct-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The patient did get the shot because he did not want to get them again. The patient stated that surprised that you could get them and they did not always show a rash.  The patient was very miserable. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.