chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain, Rash macular
Clinical narrative: Patient called pharmacy 4/29/2024 1:38pm-states that the evening following his injection he had some soreness and redness at the site and below. States that he had done some lifting earlier that day helping move a friend.  He states that he took Ibuprofen. He states that he woke up the following morning and it was throbbing and still red at the site.  He states that he took the 800mg Ibuprofen he had on hand and that knocked the pain out. States that today not really painful, just the red blotch, not a rash, just red and warm.  States that the red site is not getting larger.  I encouraged him to use some  ice, and or benadryl or hydrocortisone for the red area.  I also told him to mark the site to make sure that it is not growing. He states he will watch the area but again that it is not getting any larger.  I explained that if it does begin to get larger or it begins to streak then he needs to see dr right away or if his symptoms get worse. He said that he did not have any issues with his first dose in November.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine dose was expired. No adverse effects noted.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Blood test normal, Headache, Vertigo
Clinical narrative: Approximately 3-4 hours after injection I noticed a headache. I went to bed and the next morning I woke up with extreme headache and vertigo. I had vertigo continuously for over a month and a half that was debilitating. I was seen by a doctor thinking it was an ear issue and had bloodwork but everything came up normal. I was referred to the specialist.
Age: 1.83
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: ACT-HIB, which had multiple excursions/ one of the two vaccines affected by the excursion was administered with no reported adverse event; ACT-HIB, which had multiple excursions/ one of the two vaccines affected by the excursion was administered with no reported adverse event; Initial information received on 22-Apr-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 22 months old female patient and reporter reported  HIB (PRP/T) VACCINE [ACT-HIB], which had multiple excursions/ one of the two vaccines affected by the excursion was administered with no reported adverse event.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot number: UJ855AA) (Expiry date: 22-Mar-2024) via intramuscular route in the left thigh for immunization.  On an unknown date,  the reporter reported  HIB (PRP/T) VACCINE, which had multiple excursions/ one of the two vaccines affected by the excursion was administered with no reported adverse event (product storage error; latency: unknown) (poor quality product administered; latency: same day).  It was reported, She stated that one of the two vaccines affected by the excursion was administered. She wanted to know if they will need to readminister the affected vaccine. A nurse is calling to report some vaccines that were potential administered post excursion and is requesting for more information on how to handle the situation. This situation is pre-assessed as a medication error/an inappropriate use because the vaccine was administered post excursion. She initially called under the impression that the punctured IPOL and VAXELIS were administered post-excision but later discovered they were actually administered before the excursion.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose given was expired. No adverse effects noted.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired. No adverse effects noted.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose was expired, no adverse effects noted
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Moderna Spikevax vaccination. Product expired 3/31/24. Patient was given the vaccine on 4/24/24. We are waiting to hear from Moderna about patient safety concerns.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given was expired, no adverse effects noted
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose was expired, no adverse effects noted
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dysphonia, Dyspnoea, Erythema, Injection site swelling
Clinical narrative: Delayed trouble breathing, coughing, hoarseness -- red arm, swelling at injection site, and stiffness/pain in arm
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Delayed trouble breathing, coughing, hoarseness -- red arm, swelling at injection site, and stiffness/pain in arm
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired no adverse effects noted
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired. No adverse effects noted.
Age: 20.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: This Tdap vaccine was given instead if the intended influenza vaccine that patient consented to. Patient is currently 19 weeks and 3 days pregnant.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Medical Assistant gave Fluzone instead of COVID vaccine
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Covid vaccine expired. No adverse effects noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered
Clinical narrative: Kinrix was given and 4/26/2024 it was Exp. on 4/14/2024
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Dry skin, Fatigue, Hypersomnia, Peripheral coldness
Clinical narrative: cold hands, feel like frost bitten hands, very dry hands, hands feel like sandpaper, very tired, body fatique,  sleeping 11-13 hrs for first 2 months from onset of reactions.
Age: 67.0
Sex: M
Vaccine: PNC20
Symptoms: Blood test normal, Fatigue, Feeling abnormal, HIV test negative, Hepatitis C test negative
Clinical narrative: He go this vaccine, asked the nurse who was mumbling, he looked at the vaccine and it had some water coming out of it, and she gave him the shot and put it in the sharps container and said that he could go.  He left, went home and about 2-3 days later he reported it to Dr. through the portal and she said that she would get back to him.  The next day he got a message that these things happen and that it may take 3-4 days to go away, and he then reported it to the hospital and they are still waiting on him to give a report.  He started body aches and pains, which did not go away.  Now he is feeling drowsy, getting tired, and his body is not the same.  This is different from his usual body aches/pains from arthritis.  He went to another doctor who did some tests, and asked if she would continue to monitor him for a few months and she said no.  He went to the ER and they told him that he could come back and get treated or monitored.  He may get another doctor as he does not feel that she is listening.  He told her that he also had a similar reaction to the RSV vaccine, and had a trigger finger and had a similar reaction to possibly a steroid that was injected into his finger.  He also had hives on his body, but after 6 months of testing, testing, and was tested for anything that a needle could cause damage and that was all ruled out.  He then had this vaccine, and feels that it was due to that, but the doctor is not saying that.  He is going to test again for another 6 months and see if that finds anything.  If those tests are normal then everybody is off the hook.  He does not drink, smoke, date or do anything wrong.  He has had blood clots in his legs in 2022 not related to a vaccine.  They gave him Eliquis for that, and the doctor at that time tried to take him off of the Eliquis and went to a hemotologist and she tested him several times and said that he did not have to return.  His PCP also did some blood work, and she checked for HIV, hepatitis C and those were negative.  He is planning on going to another doctor around 5/15 or 16th and go to another doctor and continue to see other doctors until 4-6 months to see if everything is fine and negative.   He did not have any reaction with the shingles vaccines.
Age: 67.0
Sex: M
Vaccine: PNC20
Symptoms: Laboratory test normal, Pain, Somnolence, Urticaria, X-ray
Clinical narrative: He go this vaccine, asked the nurse who was mumbling, he looked at the vaccine and it had some water coming out of it, and she gave him the shot and put it in the sharps container and said that he could go.  He left, went home and about 2-3 days later he reported it to Dr. through the portal and she said that she would get back to him.  The next day he got a message that these things happen and that it may take 3-4 days to go away, and he then reported it to the hospital and they are still waiting on him to give a report.  He started body aches and pains, which did not go away.  Now he is feeling drowsy, getting tired, and his body is not the same.  This is different from his usual body aches/pains from arthritis.  He went to another doctor who did some tests, and asked if she would continue to monitor him for a few months and she said no.  He went to the ER and they told him that he could come back and get treated or monitored.  He may get another doctor as he does not feel that she is listening.  He told her that he also had a similar reaction to the RSV vaccine, and had a trigger finger and had a similar reaction to possibly a steroid that was injected into his finger.  He also had hives on his body, but after 6 months of testing, testing, and was tested for anything that a needle could cause damage and that was all ruled out.  He then had this vaccine, and feels that it was due to that, but the doctor is not saying that.  He is going to test again for another 6 months and see if that finds anything.  If those tests are normal then everybody is off the hook.  He does not drink, smoke, date or do anything wrong.  He has had blood clots in his legs in 2022 not related to a vaccine.  They gave him Eliquis for that, and the doctor at that time tried to take him off of the Eliquis and went to a hemotologist and she tested him several times and said that he did not have to return.  His PCP also did some blood work, and she checked for HIV, hepatitis C and those were negative.  He is planning on going to another doctor around 5/15 or 16th and go to another doctor and continue to see other doctors until 4-6 months to see if everything is fine and negative.   He did not have any reaction with the shingles vaccines.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone increased, Chest pain, Echocardiogram, Electrocardiogram, Electrocardiogram T wave abnormal
Clinical narrative: PATIENT DEVELOPED ATYPICAL CHEST PAIN NONSPECIFIC T-WAVE CHANGES AND SMALL PERICARDIAL EFFUSION CONSISENT WITH MRNA COVID VACCINE PERICARDITIS.  ADDITIONALLY SHE HAD TRANSIENT HYPOTHYROIDISM AND ELEVATED TSH THAT RESOLVED WITHOUT THYROID REPLACEMENT THERAPY.  TREATED WITH COLCHICINE AND PROTOCOL.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypothyroidism, Laboratory test, Pericardial effusion
Clinical narrative: PATIENT DEVELOPED ATYPICAL CHEST PAIN NONSPECIFIC T-WAVE CHANGES AND SMALL PERICARDIAL EFFUSION CONSISENT WITH MRNA COVID VACCINE PERICARDITIS.  ADDITIONALLY SHE HAD TRANSIENT HYPOTHYROIDISM AND ELEVATED TSH THAT RESOLVED WITHOUT THYROID REPLACEMENT THERAPY.  TREATED WITH COLCHICINE AND PROTOCOL.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine that was 3 days past its expiration date.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Diarrhoea haemorrhagic, Laboratory test normal
Clinical narrative: Patient developed bloody diarrhea. She was evaluated in the emergency room of the Hospital and all testing was negative. She was discharged without any medication and recovered within a few days.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given RSV vaccine however she had already received it at a different pharmacy. No side effects were reported
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: PATIENT STARTED SATURDAY WITH ITCHING AND HAD A RASH ALL OVER. DR. GAVE PATIENT STEROIDS BY MOUTH AND ALSO TRIAMCINOLONE CREAM
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine 3 days after expiration date.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Swelling face
Clinical narrative: Facial swelling
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: administered PENTACEL using the incorrect dilunet (sterile water) and did not mix the DTaP-IPV component with no reported AE; Initial information received on 23-Apr-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 2 months old female patient who was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] using the incorrect dilunet (sterile water) and did not mix the dtap-ipv component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included nelipepimut s (neuvax); and rotavirus vaccine (rotavirus vaccine) for immunisation.  On 09-Apr-2024, the patient received 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ973AA) (Expiry date: 19-Nov-2024) (Strength: standard) (Frequency: once) via intramuscular route in the left thigh for immunization.  On 09-APR-2024, the patient was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine using the incorrect dilunet (sterile water) and did not mix the dtap-ipv component with no reported adverse event (product preparation error) (latency: same day).  It was reported, RN reporting that 2 patients, who are twins, were administered PENTACEL using the incorrect dilunet (sterile water) and did not mix the DTaP-IPV component. This situation is pre-assessed as a medication error/an inappropriate use due to use of the wrong diluent.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: ERRONOUSLY ADMINISTERED PT A 3RD DOSE OF SHINGRIX
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Tinnitus
Clinical narrative: The day following initial vaccine I experienced Tinnitus which continues to this date.   Constant ringing in my ears, it never ends.   Went to acupuncturist in June 2021, went to audiologist June '21,  nothing resolved
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Hypoaesthesia, Joint stiffness, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Upper arm soreness within a couple of days after vaccine. Bruised arm a day after vaccine. Loss of function in left arm. A few days later, left mouth went numb. Today there is tightness / stiffness in left hip.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Afib
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Muscle strain, Musculoskeletal stiffness
Clinical narrative: I was given my final HPV shot on Feb. 27th in the morning. The nurse administered it in my left arm, her right side, as I had requested in my previous two shots of the series. Upon injection, I felt extreme pain in my arm. I was unsure if it was the usual soreness that one may get with an HPV shot but I realized it was significantly worse by the second day. I could not move my arm without feeling extreme pain and stiffness. There was shooting pain and numbness on other days. I could not lift it above my head or behind my back. It has been like this for over two months. I went to urgent care where I was prescribed a muscle relaxer and physical therapy as the doctor was unsure what I had. I am now in physical therapy and working to regain movement in my left arm through a combination of massages and exercises and stretches.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity
Clinical narrative: I was given my final HPV shot on Feb. 27th in the morning. The nurse administered it in my left arm, her right side, as I had requested in my previous two shots of the series. Upon injection, I felt extreme pain in my arm. I was unsure if it was the usual soreness that one may get with an HPV shot but I realized it was significantly worse by the second day. I could not move my arm without feeling extreme pain and stiffness. There was shooting pain and numbness on other days. I could not lift it above my head or behind my back. It has been like this for over two months. I went to urgent care where I was prescribed a muscle relaxer and physical therapy as the doctor was unsure what I had. I am now in physical therapy and working to regain movement in my left arm through a combination of massages and exercises and stretches.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Tremor
Clinical narrative: A few minutes after vaccination patient developed chest tightness and shortness of breath. She also complained of light headedness, dizziness, and shakiness.  Emergency services were called and she was transported by ambulance to the hospital for further evaluation.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy colon, Condition aggravated, Dysaesthesia, Electrocardiogram, Immunisation reaction
Clinical narrative: PFIZER #1 2/4/2021 PFIZER #2 2/25/2021 DEVELOPED DYSESTHESIAS IN EXTREMITIES, POST-EXERTIONAL MALAISE, AND WORSENED INFLAMMATORY BOWEL DISEASE.  DIAGNOSIS IS MRNA COVID VACCINE SMALL FIBER NEUROPATHY.  TREATED WITH NALTREXONE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inflammatory bowel disease, Laboratory test, Malaise, Small fibre neuropathy
Clinical narrative: PFIZER #1 2/4/2021 PFIZER #2 2/25/2021 DEVELOPED DYSESTHESIAS IN EXTREMITIES, POST-EXERTIONAL MALAISE, AND WORSENED INFLAMMATORY BOWEL DISEASE.  DIAGNOSIS IS MRNA COVID VACCINE SMALL FIBER NEUROPATHY.  TREATED WITH NALTREXONE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: DTAP/IPV component was drawn up and was given without reconstituting with HIB component, with no reported adverse event; Initial information received on 23-Apr-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves an unknown age and unknown gender patient and the reporter reported dtap/ipv component was drawn up and was given without reconstituting with hib component, with no reported adverse event with diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (strength, lot number, expiry date: unknown) via unknown route in unknown administration site for Immunization and dtap/ipv component was drawn up and was given without reconstituting with hib component, with no reported adverse event (single component of a two-component product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: administered PENTACEL using the incorrect dilunet (sterile water) and did not mix the DTaP-IPV component with no reported adverse event; Initial information received on 23-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2-month-old male patient was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] using the incorrect dilunet (sterile water) and did not mix the dtap-ipv component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine for Immunisation.  On 09-Apr-2024, the patient received a 0.5 ml total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength, expiry date: unknown) (lot: UJ973AA) via intramuscular route in the left thigh for prophylactic vaccination (immunization) and patient was administered pentacel using the incorrect dilunet (sterile water) and did not mix the dtap-ipv component with no reported adverse event (product preparation error) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 73.0
Sex: M
Vaccine: FLUA4
Symptoms: Diarrhoea, Dizziness, Vomiting
Clinical narrative: Diarrhea; Dizziness; Vomiting; This spontaneous case, initially received on 19-Apr-2024, was reported by a health authority and concerns an elderly male patient.  Administration of company suspect drug:  On 19-Oct-2022, the patient received Fluad Quadrivalent ((influenza vaccine inact sag 4v) for unknown indication. Route of administration: Intramuscular. Anatomical location right arm..Lot number: 346390.No additional suspect drugs.  Adverse reactions/events and outcomes:  On 25-Oct-2022, the patient experienced Diarrhea (outcome: Not Reported), Dizziness (outcome: Not Reported), Vomiting (outcome: Not Reported).  Non-drug treatment/Other action taken:  Fluad Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter did not provide a causality assessment. In addition, the event was considered as non-serious.; Reporter's Comments: Causal role of Fluad Quadrivalent  is assessed as possibly related for the events of diarrhea, dizziness and vomiting, due to plausible temporal relationship.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Pain, Swelling
Clinical narrative: swellen, red, painfull, lump went back to pharmacy and thay to me to put ice & tyatnol Thay put it in the left arm.
Age: 1.33
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC,
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but  the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in 49-year-old male health care worker and opera singer. Victim was extremely active on social media posting until October 19, 2023. Online obituary indicates DOD 11/02/2023. DOSE#1 on 03/13/2021 LOT#UNK. Information on subsequent inoculations unknown. Nature of adverse events prior to death unknown. Since victims normal activity was disrupted it's likely the adverse event occurred on 10/20/2023.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in 64-year-old male recipient of EUA medical countermeasure aka Moderna COVID-19 vaccine. Victim was likely inoculated a second time in 2021 after DOSE#1. DOSE#1 Date 02/04/2021 LOT#012M20A. A review of social media indicates spinal taps in November 2015. Other prior existing medical conditions unknown. Other information about subsequent inoculations aka boosters unknown. DOD 03/30/2024
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Fatigue, Peripheral swelling
Clinical narrative: Redness/swelling than went down to her elbow and lasted 4 days. Also weakness and fatigue that lasted a couple of days. This was reported today 4/29/24 and all symptoms have resolved.
Age: 75.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Chills, Decreased appetite, Influenza virus test negative, Insomnia, Pyrexia
Clinical narrative: fever, chills, can't sleep, no appetite...
Age: 75.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: SARS-CoV-2 test negative
Clinical narrative: fever, chills, can't sleep, no appetite...
Age: 37.0
Sex: M
Vaccine: COVID19, FLU4, TDAP
Symptoms: Grunting, Heart rate decreased, Loss of consciousness, Musculoskeletal stiffness, Pallor
Clinical narrative: Patient became pale, and passed out where he was unconscious for about 45 seconds, then he yelled/grunted and became very stiff and had seizure like activity while he was lowered to the floor, waking up about 5 seconds after that. He was then alert and oriented. Vitals take, he was given a cool cloth and a fan placed on him. 911 was called to severity of reaction and possible seizure activity, while squad was here, he had another episode while on monitor and his HR dropped into the 40s, he passed out again for about 10 seconds. Squad took him to the ER for evaluation.
Age: 37.0
Sex: M
Vaccine: COVID19, FLU4, TDAP
Symptoms: Screaming, Seizure like phenomena
Clinical narrative: Patient became pale, and passed out where he was unconscious for about 45 seconds, then he yelled/grunted and became very stiff and had seizure like activity while he was lowered to the floor, waking up about 5 seconds after that. He was then alert and oriented. Vitals take, he was given a cool cloth and a fan placed on him. 911 was called to severity of reaction and possible seizure activity, while squad was here, he had another episode while on monitor and his HR dropped into the 40s, he passed out again for about 10 seconds. Squad took him to the ER for evaluation.
Age: 9.0
Sex: F
Vaccine: MMR
Symptoms: Injection site rash
Clinical narrative: She developed a rash near vaccine site. She was observed in clinic and had stable vital signs. The rash was fading so she was discharged.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Patient complains of pain at injection site area that was noticeable immediately after administration and persisted after returning home. They state that they have limited range of motion in the arm due to the pain and that their primary care provider has referred them to a physical therapist to regain mobility all of these months later.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: I started to get loud ringing in my ear and was diagnosed with Tinnitus a few months after the vaccine
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Blood test, Fatigue, Sluggishness, Type 1 diabetes mellitus
Clinical narrative: Started losing weight u controllably, tired, sluggish, fatigued, was diagnosed with type 1 diabetes. No family history of diabetes.
Age: 78.0
Sex: M
Vaccine: PNC20, RSV, VARZOS
Symptoms: Abdominal pain upper, Dizziness, Vision blurred
Clinical narrative: Dizzy, Blurred vision, stomach pain
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Lethargy, Nausea, Peripheral swelling
Clinical narrative: complaints of stomach pain/Stomach Cramping; vomiting; extreme tiredness; pain at the injection site; explosive diarrhea; extreme tiredness with lethargy/Lethargic; Left arm swollen; Nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included the patient had never had a adverse event to any of the vaccines he had received in the past.   On 17-APR-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). In APR-2024, an unknown time after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea). On 17-APR-2024, the patient experienced injection site pain (Verbatim: pain at the injection site), explosive diarrhea (Verbatim: explosive diarrhea), lethargy (Verbatim: extreme tiredness with lethargy/Lethargic) and swelling arm (Verbatim: Left arm swollen). On 18-APR-2024, the patient experienced stomach cramps (Verbatim: complaints of stomach pain/Stomach Cramping), vomiting (Verbatim: vomiting) and tiredness (Verbatim: extreme tiredness). Shingrix was discontinued. The outcome of the injection site pain, explosive diarrhea, lethargy, swelling arm, stomach cramps, vomiting, tiredness and nausea were not resolved.   It was unknown if the reporter considered the injection site pain, explosive diarrhea, lethargy, swelling arm, stomach cramps, vomiting, tiredness and nausea to be related to Shingrix.     It was unknown if the company considered the injection site pain, explosive diarrhea, lethargy, swelling arm, stomach cramps, vomiting, tiredness and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2024 The patient self-reported this case. All of the events the patient had mentioned today (on the day of reporting) had experienced having leg arm swollen with pain at the injection site of the leg deltoid that has not resolved. The patient complaints of stomach pain with explosive diarrhea, vomiting and nausea that was still ongoing currently.  The patient also stated having extreme redness with lethargy that was still ongoing.  The patient stated his redness was better but still ongoing. Reporter stated he did call where he sees a Healthcare provider and was advised to go the Emergency Room to be seen. Reporter stated he refused he would wait and not go to the ER. HCP was aware of these symptoms. Reporter stated he would not be receiving the 2nd dose of Shingrix in the future. The reporter was not sure which HCP he would see due to the changing every 2 months which provider he would see. Extreme tiredness Vomiting  Stomach Cramping 12 hours. The reporter requested to consent the follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Injection site pain, Lethargy
Clinical narrative: complaints of stomach pain/Stomach Cramping; vomiting; extreme tiredness; pain at the injection site; explosive diarrhea; extreme tiredness with lethargy/Lethargic; Left arm swollen; Nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included the patient had never had a adverse event to any of the vaccines he had received in the past.   On 17-APR-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). In APR-2024, an unknown time after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea). On 17-APR-2024, the patient experienced injection site pain (Verbatim: pain at the injection site), explosive diarrhea (Verbatim: explosive diarrhea), lethargy (Verbatim: extreme tiredness with lethargy/Lethargic) and swelling arm (Verbatim: Left arm swollen). On 18-APR-2024, the patient experienced stomach cramps (Verbatim: complaints of stomach pain/Stomach Cramping), vomiting (Verbatim: vomiting) and tiredness (Verbatim: extreme tiredness). Shingrix was discontinued. The outcome of the injection site pain, explosive diarrhea, lethargy, swelling arm, stomach cramps, vomiting, tiredness and nausea were not resolved.   It was unknown if the reporter considered the injection site pain, explosive diarrhea, lethargy, swelling arm, stomach cramps, vomiting, tiredness and nausea to be related to Shingrix.     It was unknown if the company considered the injection site pain, explosive diarrhea, lethargy, swelling arm, stomach cramps, vomiting, tiredness and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2024 The patient self-reported this case. All of the events the patient had mentioned today (on the day of reporting) had experienced having leg arm swollen with pain at the injection site of the leg deltoid that has not resolved. The patient complaints of stomach pain with explosive diarrhea, vomiting and nausea that was still ongoing currently.  The patient also stated having extreme redness with lethargy that was still ongoing.  The patient stated his redness was better but still ongoing. Reporter stated he did call where he sees a Healthcare provider and was advised to go the Emergency Room to be seen. Reporter stated he refused he would wait and not go to the ER. HCP was aware of these symptoms. Reporter stated he would not be receiving the 2nd dose of Shingrix in the future. The reporter was not sure which HCP he would see due to the changing every 2 months which provider he would see. Extreme tiredness Vomiting  Stomach Cramping 12 hours. The reporter requested to consent the follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Peripheral swelling, Vomiting
Clinical narrative: complaints of stomach pain/Stomach Cramping; vomiting; extreme tiredness; pain at the injection site; explosive diarrhea; extreme tiredness with lethargy/Lethargic; Left arm swollen; Nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included the patient had never had a adverse event to any of the vaccines he had received in the past.   On 17-APR-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). In APR-2024, an unknown time after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea). On 17-APR-2024, the patient experienced injection site pain (Verbatim: pain at the injection site), explosive diarrhea (Verbatim: explosive diarrhea), lethargy (Verbatim: extreme tiredness with lethargy/Lethargic) and swelling arm (Verbatim: Left arm swollen). On 18-APR-2024, the patient experienced stomach cramps (Verbatim: complaints of stomach pain/Stomach Cramping), vomiting (Verbatim: vomiting) and tiredness (Verbatim: extreme tiredness). Shingrix was discontinued. The outcome of the injection site pain, explosive diarrhea, lethargy, swelling arm, stomach cramps, vomiting, tiredness and nausea were not resolved.   It was unknown if the reporter considered the injection site pain, explosive diarrhea, lethargy, swelling arm, stomach cramps, vomiting, tiredness and nausea to be related to Shingrix.     It was unknown if the company considered the injection site pain, explosive diarrhea, lethargy, swelling arm, stomach cramps, vomiting, tiredness and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2024 The patient self-reported this case. All of the events the patient had mentioned today (on the day of reporting) had experienced having leg arm swollen with pain at the injection site of the leg deltoid that has not resolved. The patient complaints of stomach pain with explosive diarrhea, vomiting and nausea that was still ongoing currently.  The patient also stated having extreme redness with lethargy that was still ongoing.  The patient stated his redness was better but still ongoing. Reporter stated he did call where he sees a Healthcare provider and was advised to go the Emergency Room to be seen. Reporter stated he refused he would wait and not go to the ER. HCP was aware of these symptoms. Reporter stated he would not be receiving the 2nd dose of Shingrix in the future. The reporter was not sure which HCP he would see due to the changing every 2 months which provider he would see. Extreme tiredness Vomiting  Stomach Cramping 12 hours. The reporter requested to consent the follow up.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no symptomatic adverse events were reported; Inbound call from nurse calling to report temperature excursions that occurred for GARDASIL-9.  Vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023.; This spontaneous report was received from a registered nurse and refers to a 14-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  Reporter stated that HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023 (temperature excursion on 07-JUN-2023 was 33F for 3 hours; on 13-JUN-2023 was 60F for 4 hours 30 minutes; from 13 to 23-JUN-2023 was 34.10F for 240 hours; on 30-NOV-2023 was 52F for 5 hours and 45 minutes, and on 01-DEC-2023 was 51.78F for 192 hours).   On 22-SEP-2023, the patient was vaccinated with an improperly storage dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, product quantity: 1, lot #W010663, expiration date: 11-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No symptomatic adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/; improperly stored ROTATEQ was administered to 2 patients; 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 provided.  On 22-APR-2024, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #2003148, expiration date: 31-MAY-2025, (Product storage error) administered orally for prophylaxis (strength, dose and units were not provided). The storage characteristics were the following: temperature: 57.5 F, time frame: 1 hour 45 minutes 0 seconds . No previous temperature excursion. No additional adverse events.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2404USA010138:
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE/PQC.; Patient was scheduled to receive a first dose of PROQUAD but was instead inadvertently given a first dose of PROQUAD and a first dose of VARIVAX; This spontaneous report has been received from other health professional (nurse) concerning to a 12-months-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 01-APR-2024, the patient was scheduled to receive a first dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD), but was instead inadvertently vaccinated with the first dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection at a dose of 0.5 milliliter once and the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection at a dose of 0.5 milliliter once, both vaccines administered as prophylaxis (routes and anatomical locations of administration, lot numbers and expiration dates of the vaccines were not reported) (accidental overdose). There was no additional adverse event or product quality complaint (PQC) (no adverse event).
Age: 16.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 Year Old Received Heplisav-B; Initial report received on 04-Apr-2024.  A nurse reported that a 16-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 04-Apr-2024, the patient received a dose of HEPLISAV-B (lot # 944906, expiration date 30-Apr-2026, and NDC # 43528 003 05) intramuscular in the right deltoid.   The patient was 16-years-old at the time of vaccination.  No adverse events were reported. No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 25.0
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received A Different Hepatitis B Vaccine, Then Received Heplisav B; Initial report received on 08-Apr-2024.  A pharmacist reported that a 25-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after receiving a different hepatitis B vaccine.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 17-Apr-2023, the patient received the first dose of a hepatitis B vaccine (lot #, expiration date, NDC #, route, and site).  On 17-May-2023, the patient received the second dose of a hepatitis B vaccine [HEPLISAV-B (lot # 941060, expiration date 02-Dec-2024, and NDC # 43528-003-05)] intramuscularly in the left arm from a pharmacist.    No adverse events from the vaccine were reported. No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 71.0
Sex: U
Vaccine: HEP
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Chills after use; Third dose administered; Nausea after use; Vomiting after use; Initial report received on 08-Apr-2024 and 09-Apr-2024.  A nurse reported that a 71-year-old female (race and ethnicity not provided) received a third dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed severe nausea, vomiting, and chills.  The patient is on dialysis.  The patient has an allergy to latex (skin reaction) and codeine (nausea and vomiting).   No relevant concomitant medications were reported.    On 02-Jan-2024, the patient received the first dose of HEPLISAV-B (lot #, expiration date, NDC #, route, and site not reported).  On 05-Feb-2024, the patient received the second dose of HEPLISAV-B (lot #, expiration date, NDC #, route, and site not reported).  On an unknown date, after receiving the second dose of HEPLISAV-B, the patient experienced nausea. The patient did not link the nausea to the vaccination at the time.  On 07-Mar-2024, the patient received the third dose of HEPLISAV-B (lot # 945139, expiration date 22-Jan-2026, and NDC # 43528-003-01) intramuscularly in the right deltoid.   On 07-Mar-2024, the same day as having received the third dose of HEPLISAV-B, the patient experienced nausea, vomiting, and chills. The patient presented to the emergency department for nausea and vomiting. The patient waited for a long period of time and ended up leaving the emergency department as she was feeling better. The patient stated her symptoms of nausea and vomiting self-resolved. No treatment was provided in the emergency department.   No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Age: 12.0
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 Year Old Received Heplisav-B; Initial report received on 11-Apr-2024.  A registered nurse reported that a 12-year-old female (race and ethnicity not provided) received a dose with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.   On 11-Apr-2024, the patient received a dose of HEPLISAV-B (Lot number, expiration date, NDC number, and injection site were unknown; administration route was not reported). The patient was 12 years old at the time of immunization. The patient has not reported any side effects.  No other information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 21.0
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: 17 Weeks Pregnant and Received Heplisav-B; Initial report received on 12-Apr-2024.  A physician reported that a 21-year-old pregnant female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had no known allergies.   The last menstrual period date, pregnancy history, pregnancy risk factors, and estimated date of delivery were not reported.   On 05-Mar-2024, the patient received a dose of HEPLISAV-B (Lot number 943192, expiration date 08 Mar-2024, NDC number 43528-003-05; route of administration not reported) in the right deltoid. The patient was at 17 weeks pregnant. No adverse reactions have been reported.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Balance disorder, Brain fog, Head discomfort, Memory impairment, Vertigo
Clinical narrative: Vestibular disorder - imbalance, visual vertigo, brain fog, head pressure, memory issues