chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Vaccination error
Clinical narrative: No adverse event reported. This is to report a vaccine error. Patient received one dose of Moderna bivalent on 09/26/23 and a dose of Pfizer bivalent on 12/11/2023
Age: 18.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Lip swelling, Peripheral swelling
Clinical narrative: PATIENT SAYS HE HAD SWELLING IN HAND ON THE SAME SIDE THE VACCINATION WERE GIVEN, Pt says that 4 hours after his vaccination he had swelling of his hand and he felt his lips were swollen, he denied any itchy swelling elsewhere he went to the ER and was given Benadryl and sent home, at present he has no symptoms.
Age: 58.0
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Breast induration, Breast swelling, Chest pain, Decreased appetite, Dizziness
Clinical narrative: under 17 - other vaccine was a routine allergy shot for cat/molds. I had expected side effects & did have: pain/swelling at injeciton site, myalgia/fatique/headach/fever/nausea. I expected this due to my "overactive" aka allergic immune system. BUT I also have/had: heat at injection site (improving), intermittent sweating/dizziness, no/poor appetite AND very sharp, stabbing, frequent/intermittent pain in left chest near sternum as well as firm & swollen breasts as if I was a week into taking birth control for the first time. The stabbing pain felt as if an ice pick was punched through my chest to my back, 8-9/10. Considered going to urgent care & would have today if the pain frequency & intensity had not lessened
Age: 58.0
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Fatigue, Headache, Hyperhidrosis, Injection site pain, Injection site swelling
Clinical narrative: under 17 - other vaccine was a routine allergy shot for cat/molds. I had expected side effects & did have: pain/swelling at injeciton site, myalgia/fatique/headach/fever/nausea. I expected this due to my "overactive" aka allergic immune system. BUT I also have/had: heat at injection site (improving), intermittent sweating/dizziness, no/poor appetite AND very sharp, stabbing, frequent/intermittent pain in left chest near sternum as well as firm & swollen breasts as if I was a week into taking birth control for the first time. The stabbing pain felt as if an ice pick was punched through my chest to my back, 8-9/10. Considered going to urgent care & would have today if the pain frequency & intensity had not lessened
Age: 58.0
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Injection site warmth, Myalgia, Nausea, Pyrexia
Clinical narrative: under 17 - other vaccine was a routine allergy shot for cat/molds. I had expected side effects & did have: pain/swelling at injeciton site, myalgia/fatique/headach/fever/nausea. I expected this due to my "overactive" aka allergic immune system. BUT I also have/had: heat at injection site (improving), intermittent sweating/dizziness, no/poor appetite AND very sharp, stabbing, frequent/intermittent pain in left chest near sternum as well as firm & swollen breasts as if I was a week into taking birth control for the first time. The stabbing pain felt as if an ice pick was punched through my chest to my back, 8-9/10. Considered going to urgent care & would have today if the pain frequency & intensity had not lessened
Age: 58.0
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Heart rate irregular, Muscle spasms
Clinical narrative: under 17 - other vaccine was a routine allergy shot for cat/molds. I had expected side effects & did have: pain/swelling at injeciton site, myalgia/fatique/headach/fever/nausea. I expected this due to my "overactive" aka allergic immune system. BUT I also have/had: heat at injection site (improving), intermittent sweating/dizziness, no/poor appetite AND very sharp, stabbing, frequent/intermittent pain in left chest near sternum as well as firm & swollen breasts as if I was a week into taking birth control for the first time. The stabbing pain felt as if an ice pick was punched through my chest to my back, 8-9/10. Considered going to urgent care & would have today if the pain frequency & intensity had not lessened
Age: 58.0
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Breast induration, Breast swelling, Chest pain, Decreased appetite, Dizziness
Clinical narrative: Add to temporary # 100 7972, submitted 12-13-2023 7:58 pm as additional description could not be submitted and downloaded.  ?As a RN & a person who has had experience with severe muscle spasms, with palpatation on the left side of my sternum, I felt  chords  of what felt like muscle spasms between or around my ribs from the sternum out toward my left breast. I sprayed Magnesium (Mg) spray on this area about every 3 hours & took oral Mg, 150 mg. The Mg helps a little. I also hydrated. Today, 12/13/2023, I have taken the same along with 1.25mg of Cortef which I usually only take on allergy shot days.  After reviewing several articles attached to a google search re: muscle spasms & vaccines, where most of the articles related to Covid-19 vaccines, there were a few comments as follows:  Muscle spasms to fasciitis have occurred with viral vaccines other that Covid-19 vaccines including flu, chicken pox, HPV, & shingles.  Intense mucles spams are reported rarely, in part, it is thought, that patients do not self-report & those patients who are hospitalized with the muscle spasms where the hospital reports are rare. It is possible that intense muscle spasms have occurred more than thought & reported.   Hence, I am reporting my experience, especially since, if I had not been a RN, I may have thought I was having a heart attack.   I also had a slightly irregular heartbeat on palpatation & use of a O2 sat monitor with a heart rate of 98 at rest, assumably due to the fever (99.5F, where my normal is 97.5F).
Age: 58.0
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Fatigue, Headache, Hyperhidrosis, Injection site pain, Injection site swelling
Clinical narrative: Add to temporary # 100 7972, submitted 12-13-2023 7:58 pm as additional description could not be submitted and downloaded.  ?As a RN & a person who has had experience with severe muscle spasms, with palpatation on the left side of my sternum, I felt  chords  of what felt like muscle spasms between or around my ribs from the sternum out toward my left breast. I sprayed Magnesium (Mg) spray on this area about every 3 hours & took oral Mg, 150 mg. The Mg helps a little. I also hydrated. Today, 12/13/2023, I have taken the same along with 1.25mg of Cortef which I usually only take on allergy shot days.  After reviewing several articles attached to a google search re: muscle spasms & vaccines, where most of the articles related to Covid-19 vaccines, there were a few comments as follows:  Muscle spasms to fasciitis have occurred with viral vaccines other that Covid-19 vaccines including flu, chicken pox, HPV, & shingles.  Intense mucles spams are reported rarely, in part, it is thought, that patients do not self-report & those patients who are hospitalized with the muscle spasms where the hospital reports are rare. It is possible that intense muscle spasms have occurred more than thought & reported.   Hence, I am reporting my experience, especially since, if I had not been a RN, I may have thought I was having a heart attack.   I also had a slightly irregular heartbeat on palpatation & use of a O2 sat monitor with a heart rate of 98 at rest, assumably due to the fever (99.5F, where my normal is 97.5F).
Age: 58.0
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Injection site warmth, Myalgia, Nausea, Pyrexia
Clinical narrative: Add to temporary # 100 7972, submitted 12-13-2023 7:58 pm as additional description could not be submitted and downloaded.  ?As a RN & a person who has had experience with severe muscle spasms, with palpatation on the left side of my sternum, I felt  chords  of what felt like muscle spasms between or around my ribs from the sternum out toward my left breast. I sprayed Magnesium (Mg) spray on this area about every 3 hours & took oral Mg, 150 mg. The Mg helps a little. I also hydrated. Today, 12/13/2023, I have taken the same along with 1.25mg of Cortef which I usually only take on allergy shot days.  After reviewing several articles attached to a google search re: muscle spasms & vaccines, where most of the articles related to Covid-19 vaccines, there were a few comments as follows:  Muscle spasms to fasciitis have occurred with viral vaccines other that Covid-19 vaccines including flu, chicken pox, HPV, & shingles.  Intense mucles spams are reported rarely, in part, it is thought, that patients do not self-report & those patients who are hospitalized with the muscle spasms where the hospital reports are rare. It is possible that intense muscle spasms have occurred more than thought & reported.   Hence, I am reporting my experience, especially since, if I had not been a RN, I may have thought I was having a heart attack.   I also had a slightly irregular heartbeat on palpatation & use of a O2 sat monitor with a heart rate of 98 at rest, assumably due to the fever (99.5F, where my normal is 97.5F).
Age: 58.0
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Heart rate irregular, Muscle spasms
Clinical narrative: Add to temporary # 100 7972, submitted 12-13-2023 7:58 pm as additional description could not be submitted and downloaded.  ?As a RN & a person who has had experience with severe muscle spasms, with palpatation on the left side of my sternum, I felt  chords  of what felt like muscle spasms between or around my ribs from the sternum out toward my left breast. I sprayed Magnesium (Mg) spray on this area about every 3 hours & took oral Mg, 150 mg. The Mg helps a little. I also hydrated. Today, 12/13/2023, I have taken the same along with 1.25mg of Cortef which I usually only take on allergy shot days.  After reviewing several articles attached to a google search re: muscle spasms & vaccines, where most of the articles related to Covid-19 vaccines, there were a few comments as follows:  Muscle spasms to fasciitis have occurred with viral vaccines other that Covid-19 vaccines including flu, chicken pox, HPV, & shingles.  Intense mucles spams are reported rarely, in part, it is thought, that patients do not self-report & those patients who are hospitalized with the muscle spasms where the hospital reports are rare. It is possible that intense muscle spasms have occurred more than thought & reported.   Hence, I am reporting my experience, especially since, if I had not been a RN, I may have thought I was having a heart attack.   I also had a slightly irregular heartbeat on palpatation & use of a O2 sat monitor with a heart rate of 98 at rest, assumably due to the fever (99.5F, where my normal is 97.5F).
Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: pfizer covid vaccination 6month-4years not diluted so patient received undiluted contents. no known adverse event
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site warmth, Pain in extremity
Clinical narrative: Pt unable to lift her left arm pain level 8/10 at time of Urgent Care visit on 12/13/2023.  60w x50L red circular induration on left arm about 5 fingers' down from shoulder and warm to the touch.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: rash/red/itching, patient applied clotrimazole topically - recommended this stop and to used hydrocortisone or Benadryl
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Tinnitus bilateral
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocrodatis. I was admitted into the hospital
Age: 83.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Injection site pain
Clinical narrative: Patient came to pharmacy on 12/13/2023 and reported pain that comes and goes on his left arm (Spikevax vaccine injection site)
Age: 47.0
Sex: F
Vaccine: HEPAB
Symptoms: Confusional state, Dizziness, Seizure
Clinical narrative: at 3:15 pm on 12-13-23 , I  gave her  a twinrix shot , 3 to 5 minutes after , she started having seizure( she said) but i did not notice any physical  movement , she also stated she is confused and dizzy , so we  right away called EMS , she was ok before leaving pharmacy
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus- chronic both ears
Age: 20.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: After the administration of the Fluzone vaccine, patient stated that she was getting dizzy. I had her continue to sit in chair and patient stated that she was starting to feel faint and then passed out for 30 seconds. She then woke back up and sat in the chair for a few more mins before proceeding to lay down on the floor and drink her Boba tea. After about 5-10 mins, patient stated she was feeling better and proceeded to sit back in the chair to receive her COVID vaccine. She received the COVID vaccine with no reaction.  Patient sat in the pharmacy waiting area for about 15 mins  to be monitored for any other adverse reactions, none was noted and patient left the pharmacy.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Skin induration, Swelling
Clinical narrative: Large(size of adult hand ??) red, swollen, hard area on thigh
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness. Paresthesia of right/affected arm. Fully resolved after 2 weeks
Age: 60.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Limb mass, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Morning after, pt. noticed large swollen lump w/ soreness, warmth to the touch, lots of redness, "lumps" down the arm ("like a goose-egg"), for about 10 days
Age: 1.67
Sex: F
Vaccine: FLU4
Symptoms: Activated partial thromboplastin time, C-reactive protein, Ear infection, Full blood count, Gait disturbance
Clinical narrative: Mom chatted with our triage nurse on 11/30/23 that starting on Tuesday 11/28 she was having pain and would not walk. Developed a rash on 11/29 on lower abdomen, back & legs. Triage nurse recommended an appt and they were seen on 11/30/23 and they were dx with purpura Henoch (Schonlein) HSP (D69.0) & ear infection.
Age: 1.67
Sex: F
Vaccine: FLU4
Symptoms: Henoch-Schonlein purpura, International normalised ratio, Metabolic function test, Pain, Prothrombin time
Clinical narrative: Mom chatted with our triage nurse on 11/30/23 that starting on Tuesday 11/28 she was having pain and would not walk. Developed a rash on 11/29 on lower abdomen, back & legs. Triage nurse recommended an appt and they were seen on 11/30/23 and they were dx with purpura Henoch (Schonlein) HSP (D69.0) & ear infection.
Age: 1.67
Sex: F
Vaccine: FLU4
Symptoms: Rash, Red blood cell sedimentation rate, Urine analysis
Clinical narrative: Mom chatted with our triage nurse on 11/30/23 that starting on Tuesday 11/28 she was having pain and would not walk. Developed a rash on 11/29 on lower abdomen, back & legs. Triage nurse recommended an appt and they were seen on 11/30/23 and they were dx with purpura Henoch (Schonlein) HSP (D69.0) & ear infection.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: The adverse reaction was very similar to reaction after the first Covid vaccine on 6/2/2023. Patient fainted in bathroom after getting out of bed the morning after the vaccination. She lost consciousness for several seconds. When she regained consciousness, she was extremely tired and felt sick. She went back to bed to sleep. She did not want to eat or drink, but she did with assistance. This continued for 48 hours. Primary care physician's office was notified. They advised that patient be monitored and to update them if condition worsened.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Loss of consciousness, Malaise, Similar reaction on previous exposure to drug, Syncope
Clinical narrative: The adverse reaction was very similar to reaction after the first Covid vaccine on 6/2/2023. Patient fainted in bathroom after getting out of bed the morning after the vaccination. She lost consciousness for several seconds. When she regained consciousness, she was extremely tired and felt sick. She went back to bed to sleep. She did not want to eat or drink, but she did with assistance. This continued for 48 hours. Primary care physician's office was notified. They advised that patient be monitored and to update them if condition worsened.
Age: 74.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Dysstasia, Gait disturbance
Clinical narrative: Guillain Barre - Onset of 10./19. Patient woke at 2:30 am and felt weak returned to bed awakened again at 5:30 am and was very weak, fell to the ground. Called EMS went to hospital was admitted to ICU was diagnosed with Guillain Barre. Patient is home now and receiving home health, home PT and OT. Patient is in wheelchair and using walker. Prior to this patient was independent and did not use a walker or wheelchair.
Age: 74.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Asthenia, Fall, Guillain-Barre syndrome, Intensive care, Loss of personal independence in daily activities
Clinical narrative: Guillain Barre - Onset of 10./19. Patient woke at 2:30 am and felt weak returned to bed awakened again at 5:30 am and was very weak, fell to the ground. Called EMS went to hospital was admitted to ICU was diagnosed with Guillain Barre. Patient is home now and receiving home health, home PT and OT. Patient is in wheelchair and using walker. Prior to this patient was independent and did not use a walker or wheelchair.
Age: 74.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Middle insomnia, Walking aid user, Wheelchair user
Clinical narrative: Guillain Barre - Onset of 10./19. Patient woke at 2:30 am and felt weak returned to bed awakened again at 5:30 am and was very weak, fell to the ground. Called EMS went to hospital was admitted to ICU was diagnosed with Guillain Barre. Patient is home now and receiving home health, home PT and OT. Patient is in wheelchair and using walker. Prior to this patient was independent and did not use a walker or wheelchair.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient reported once a week headache from 10/31 then for the next 4 weeks. has resolved for the past 2 weeks. Family and clinic wanted to report because he was given the vaccine at a time when measuring errors were occurring, giving full vial instead of 0.25ml
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: Patient reported once a week headache from 10/31 then for the next 4 weeks. has resolved for the past 2 weeks. Family and clinic wanted to report because he was given the vaccine at a time when measuring errors were occurring, giving full vial instead of 0.25ml
Age: 77.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Fatigue
Clinical narrative: Patient  said after got the vaccine on 11/6 on the same day (she did not remember how many hours later) she had running nose, no enery, felt tired, had nausea, threw up, diarrhea, her body stiff/frozen (can't not move), but had no temperature.
Age: 77.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Asthenia, Diarrhoea, Fatigue, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Patient  said after got the vaccine on 11/6 on the same day (she did not remember how many hours later) she had running nose, no enery, felt tired, had nausea, threw up, diarrhea, her body stiff/frozen (can't not move), but had no temperature.
Age: 77.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Nausea, Rhinorrhoea, Vomiting
Clinical narrative: Patient  said after got the vaccine on 11/6 on the same day (she did not remember how many hours later) she had running nose, no enery, felt tired, had nausea, threw up, diarrhea, her body stiff/frozen (can't not move), but had no temperature.
Age: 15.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Condition aggravated, Dysarthria, Dysphagia, Eyelid ptosis, Mastication disorder
Clinical narrative: Fainted; Seized up; Fluad Quadrivalent administered to 15-year-old patient; This spontaneous case was retrieved on 05-Dec-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2705894-1), reported by other healthcare professional and concerned a 15-year-old, female patient.   The patient's medical history and concomitant medications were not reported.  It was reported that on 29-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular (IM), anatomical location: left arm (LA), dose and indication: not reported). The batch number reported was 370679. The reported batch number was identified by Seqirus to be linked to suspect product Fluad Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product Flucelvax Quadrivalent. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent (explicitly coded as 'Inappropriate age at vaccine administration').  On the same day, immediately after receiving Fluad Quadrivalent vaccine, the patient fainted. The patient came to senses, then fainted and seized up before coming to senses again. EMS was called and emergency medical technician (EMT) came and did an assessment of patient and determined that patient could return home with father and no hospital visit was required. Vitals had returned to normal.  On the same date, the patient recovered from the events of faint and seizure.  The reporter did not provide a causality assessment.   The events of faint and seizure were considered to be medically significant by Physician.  Company comment: A 15-year-old, female patient was vaccinated with Fluad Quadrivalent (explicitly coded as 'Inappropriate age at vaccine administration'). Immediately after the vaccination, the patient fainted, then came to senses, then fainted again and seized up before coming to senses again. Emergency medical technician checked vitals and they returned to normal. Causality for seizure and syncope is assessed as possibly related, based on chronological plausibility. Inappropriate age at vaccine administration is assessed as not related per company's conventions.; Sender's Comments: A 15-year-old, female patient was vaccinated with Fluad Quadrivalent (explicitly coded as 'Inappropriate age at vaccine administration'). Immediately after the vaccination, the patient fainted, then came to senses, then fainted again and seized up before coming to senses again. Emergency medical technician checked vitals and they returned to normal. Causality for seizure and syncope is assessed as possibly related, based on chronological plausibility. Inappropriate age at vaccine administration is assessed as not related per company's conventions.
Age: 15.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Myasthenia gravis
Clinical narrative: Fainted; Seized up; Fluad Quadrivalent administered to 15-year-old patient; This spontaneous case was retrieved on 05-Dec-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2705894-1), reported by other healthcare professional and concerned a 15-year-old, female patient.   The patient's medical history and concomitant medications were not reported.  It was reported that on 29-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular (IM), anatomical location: left arm (LA), dose and indication: not reported). The batch number reported was 370679. The reported batch number was identified by Seqirus to be linked to suspect product Fluad Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product Flucelvax Quadrivalent. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent (explicitly coded as 'Inappropriate age at vaccine administration').  On the same day, immediately after receiving Fluad Quadrivalent vaccine, the patient fainted. The patient came to senses, then fainted and seized up before coming to senses again. EMS was called and emergency medical technician (EMT) came and did an assessment of patient and determined that patient could return home with father and no hospital visit was required. Vitals had returned to normal.  On the same date, the patient recovered from the events of faint and seizure.  The reporter did not provide a causality assessment.   The events of faint and seizure were considered to be medically significant by Physician.  Company comment: A 15-year-old, female patient was vaccinated with Fluad Quadrivalent (explicitly coded as 'Inappropriate age at vaccine administration'). Immediately after the vaccination, the patient fainted, then came to senses, then fainted again and seized up before coming to senses again. Emergency medical technician checked vitals and they returned to normal. Causality for seizure and syncope is assessed as possibly related, based on chronological plausibility. Inappropriate age at vaccine administration is assessed as not related per company's conventions.; Sender's Comments: A 15-year-old, female patient was vaccinated with Fluad Quadrivalent (explicitly coded as 'Inappropriate age at vaccine administration'). Immediately after the vaccination, the patient fainted, then came to senses, then fainted again and seized up before coming to senses again. Emergency medical technician checked vitals and they returned to normal. Causality for seizure and syncope is assessed as possibly related, based on chronological plausibility. Inappropriate age at vaccine administration is assessed as not related per company's conventions.
Age: 15.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Immediate post-injection reaction, Product administered to patient of inappropriate age, Seizure, Syncope
Clinical narrative: Fainted; Seized up; Fluad Quadrivalent administered to 15-year-old patient; This spontaneous case was retrieved on 05-Dec-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2705894-1), reported by other healthcare professional and concerned a 15-year-old, female patient.   The patient's medical history and concomitant medications were not reported.  It was reported that on 29-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular (IM), anatomical location: left arm (LA), dose and indication: not reported). The batch number reported was 370679. The reported batch number was identified by Seqirus to be linked to suspect product Fluad Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product Flucelvax Quadrivalent. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent (explicitly coded as 'Inappropriate age at vaccine administration').  On the same day, immediately after receiving Fluad Quadrivalent vaccine, the patient fainted. The patient came to senses, then fainted and seized up before coming to senses again. EMS was called and emergency medical technician (EMT) came and did an assessment of patient and determined that patient could return home with father and no hospital visit was required. Vitals had returned to normal.  On the same date, the patient recovered from the events of faint and seizure.  The reporter did not provide a causality assessment.   The events of faint and seizure were considered to be medically significant by Physician.  Company comment: A 15-year-old, female patient was vaccinated with Fluad Quadrivalent (explicitly coded as 'Inappropriate age at vaccine administration'). Immediately after the vaccination, the patient fainted, then came to senses, then fainted again and seized up before coming to senses again. Emergency medical technician checked vitals and they returned to normal. Causality for seizure and syncope is assessed as possibly related, based on chronological plausibility. Inappropriate age at vaccine administration is assessed as not related per company's conventions.; Sender's Comments: A 15-year-old, female patient was vaccinated with Fluad Quadrivalent (explicitly coded as 'Inappropriate age at vaccine administration'). Immediately after the vaccination, the patient fainted, then came to senses, then fainted again and seized up before coming to senses again. Emergency medical technician checked vitals and they returned to normal. Causality for seizure and syncope is assessed as possibly related, based on chronological plausibility. Inappropriate age at vaccine administration is assessed as not related per company's conventions.
Age: 20.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event
Clinical narrative: no adverse event; diluent mrk 0.7 ml/0.5mL Proquad; 20-year-old; diluent mrk 0.7 ml; This spontaneous report was received from a medical assistant referring to a 20-year-old patient of unknown gender.  The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-DEC-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, once (lot #X018730, expiration date: 06-JAN-2025; strength and route of administration were not provided) and sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion, 0.7 milliliter, once (lot #W024002, expiration date: 02-MAY-2025; strength and route of administration were not provided), administered for prophylaxis (Incorrect dose administered, Product preparation issue). The vaccine was given to the patient for unknown reason, and health care professional (HCP) was receiving an error in her system (Product administered to patient of inappropriate age). No symptoms or side effect was reported. No additional adverse event was reported.
Age: 20.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: no adverse event; diluent mrk 0.7 ml/0.5mL Proquad; 20-year-old; diluent mrk 0.7 ml; This spontaneous report was received from a medical assistant referring to a 20-year-old patient of unknown gender.  The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-DEC-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, once (lot #X018730, expiration date: 06-JAN-2025; strength and route of administration were not provided) and sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion, 0.7 milliliter, once (lot #W024002, expiration date: 02-MAY-2025; strength and route of administration were not provided), administered for prophylaxis (Incorrect dose administered, Product preparation issue). The vaccine was given to the patient for unknown reason, and health care professional (HCP) was receiving an error in her system (Product administered to patient of inappropriate age). No symptoms or side effect was reported. No additional adverse event was reported.
Sex: U
Vaccine: PNC15
Symptoms: Injection site reaction
Clinical narrative: injection site reactions fter administration of VAXNEUVANCE; This spontaneous report has been received from a physician and a consumer via company representative and refers to a 7-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection as prophylaxis (dose, route of administration, anatomical location of vaccination, lot number and expiration date were not provided).  On an unknown date (also reported as after administration of the vaccine), the patient experienced an injection site reaction (vaccination site reaction). The outcome of the event was unknown.  The causality assessment between vaccination site reaction and pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) was not provided.  This is one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-2311USA005086:
Age: 1.58
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/no PQC; Nurse reported a 19 month old was administered first dose of MMRII today, 11/20/2023 for catch up vaccination. AE filed as prescribing information denotes that the routine vaccination recommends that the first dose should be administered between 12-1; This spontaneous report was received from a nurse and refers to a 19-month-old female patient. The patient's medical history, concurrent conditions, and concomitant medications information was not reported .  On 20-NOV-2023, (reported as today) the patient received the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status validated as recombinant human albumin (rHA)), Lot No W035041 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, expiration date reported as 24-MAR-2024, but upon internal validation established as 24-MAY-2024 (dose description, route of administration and anatomical location were not provided), for prophylaxis  (product administered to patient of inappropriate age), alongside with sterile diluent (manufacturer unknown) solution for injection, validated lot #W032818, was verified to be a valid number with an expiration date reported and established as: 01-MAY-2025 (route of administration, and indication were not provided). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient has not reported any symptoms; 1 dose of VARIVAX had been administered to 1 patient after a temperature excursion.; This spontaneous report was received from an office administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not reported.  On 13-NOV-2023, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # W039294 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), expiration date reported as 11-DEC-2024; strength and route of administration were not reported) for prophylaxis after a temperature excursion (product storage error). The vaccine had been stored under 11.79 degrees Fahrenheit (F) for 35 minutes. There was no previous temperature excursion. The patient had not reported any symptoms (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No report of medical concerns or symptoms from patient involved; HCP calling to report adverse event regarding improperly stored and administered PROQUAD.  HCP stated that a temperature excursion occurred on 11/30/2023 and the PROQUAD involved was administered on 12/2/2023.  HCP confirmed no report of medical conc; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 02-DEC-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL (lot # X018729, expiration date: 06-JAN-2025, therapy type stablished as rHA) as a two dose series (route of administration, anatomical location not provided) for prophylaxis, which underwent a temperature excursion (on 30-NOV-2023) (product storage error). It was confirmed that there was no report of medical concerns or symptoms from the patient.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: no additional AE; administered 6/2/2023 and 8/4/2023; administered 6/2/2023 and 8/4/2023; This spontaneous report was received from a medical assistant referring to a 16-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 22-MAY-2020, at age of 13, 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, administered for prophylaxis (strength, lot #, expiry date, dose and route of administration were not provided). On 25-NOV-2020, 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). The patient completed a 2-dose series. Then, the patient started a 3-dose series again at the age of 16. On 02-JUN-2023 and 04-AUG-2023, the patient was vaccinated with the third and fourth doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (extra dose administered). No additional adverse event was reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Pancreatic failure
Clinical narrative: elastase pancreatic insufficiency; This spontaneous case was reported by a patient and describes the occurrence of PANCREATIC FAILURE (elastase pancreatic insufficiency) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. A57171B and 020H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (Booster, Lot Number 1805022) on 09-Mar-2021, JANSSEN COVID-19 VACCINE (Booster and Lot Number 213B21) on 05-Nov-2021; for COVID-19 prophylaxis: Moderna Covid-19 vaccine (lot number 014B22A and Dose 3) on 15-Jun-2022. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE, JANSSEN COVID-19 VACCINE and Moderna Covid-19 vaccine.   On 16-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-May-2023, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced PANCREATIC FAILURE (elastase pancreatic insufficiency) (seriousness criterion medically significant). At the time of the report, PANCREATIC FAILURE (elastase pancreatic insufficiency) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   Concomitant medication not reported.   Treatment medication not reported.  COMPANY COMMENT:  This is an spontaneous case concerns an adult female patient with medical history of Previously administered products included JANSSEN & MODERNA COVID-19 VACCINES who experienced the unexpected seriousness criteria medically significant event of pancreatic failure the same year after 5th. dose of mRNA-1273 BIVALENT .222 vaccine. Concomitant medication nor Treatment details were reported. As the patient received doses of Janssen vaccine; "interchange of vaccine products" and "revaccination with different Covid-19 vaccine" were noted in this case.    The benefit-risk relationship of mRNA-1273 BIVALENT .222 vaccine is not affected by this report.  Event´s seriousness assessed as reporting.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Polyarthritis
Clinical narrative: Significant arthritis-like symptoms in my hands and left shoulder; This serious, initial spontaneous safety report was received by Novavax on 08-DEC-2023 from a consumer via the web portal.  A female of 6 decades (54-years-old at the time of vaccination) was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect COVID-19 vaccine dose 1 in the left arm on 12-NOV-2023 at a pharmacy.  Medical history included COVID-19 on 08-MAY-2022. The individual had no allergies and no ongoing or past health conditions.  The individual was not taking any concomitant medications.  On an unspecified day in NOV-2023, within 2 weeks of vaccination, the individual experienced significant arthritis-like symptoms in her hands and left shoulder (PT: Polyarthritis) (Serious: Medically Significant). She received no treatment for the event. The individual reported the symptoms had almost completely resolved after about 2 weeks.  At the time of reporting, the event outcome of Polyarthritis was recovering/resolving.  Lot number was requested but was unknown to the reporter.; Sender's Comments: This 6 decades female experienced: Polyarthritis after vaccination with Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Polyarthritis was assessed as serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported event is considered Possible.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: testing positive; testing positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, latency 1 month after the suspect product(s) administration, outcome "unknown" and all described as "testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Patient was put on paxlovid after testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient was put on paxlovid after testing positive. This was one month post Comirnaty booster. It was unknown if patient received other medication in 2 weeks and had known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I rebounded 10 days after a negative Covid test.; I rebounded 10 days after a negative Covid test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 12:00 as dose 1, single (Lot number: HD9876) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies: Penicillin" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty original/omicron ba.4-5 (DOSE 7 (BOOSTER), SINGLE, Batch/lot number: GL0447, At time: 12:00 AM, Anatomical location: Left arm), administration date: 24Apr2023, when the patient was 70-year-old, for COVID-19 immunisation; Covid 19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid 19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid 19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 6 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "I rebounded 10 days after a negative Covid test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Negative, notes: I rebounded 10 days after a negative Covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 19Nov2023 to 23Nov2023
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Lot number: HG4680) at the age of 63 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "drug allergy" (unspecified if ongoing), notes: Name of Drug as Reported: No; Reaction: Allergy. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Nov2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Nov2023) Positive; (03Dec2023) Negative; (05Dec2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Positive test 29Nov. Took Paxlovid for 5 days (COVID-19 Treatment with Paxlovid, Date of treatment start was on 29Nov2023, Date of treatment stop was on 03Dec2023), through 03Dec2023. Got a negative covid test that night. Got another negative test on 05Dec2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: has treated two patients with polymyalgia rheumatica that developed within 2-3 weeks after receiving a COVID vaccine; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown", described as "has treated two patients with polymyalgia rheumatica that developed within 2-3 weeks after receiving a COVID vaccine". The event "has treated two patients with polymyalgia rheumatica that developed within 2-3 weeks after receiving a covid vaccine" required physician office visit. Therapeutic measures were taken as a result of polymyalgia rheumatica. Clinical course: Rheumatologist reported that she had treated two patients with polymyalgia rheumatica that developed within 2-3 weeks after receiving a COVID vaccine. She was not aware of the type of COVID vaccine (Pfizer or other brand) or whether it was initial or booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300440743 Same product, different patient/events;