chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: Vertigo, tinnitus, pressure headaches, chills, fever, weakness, fatigue
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmic migraine
Clinical narrative: Ocular migraines increase
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Pain, Pruritus, Stomatitis, Throat irritation
Clinical narrative: Burning/stinging sensation on tongue, roof of mouth,back of throat - started 1 hour after shot - treatment: oral rinse - symptoms ongoing Nose bleeds- almost daily - started 8 hours after shot - treatment : applying pressure, naso gel, neosporin - symptoms ongoing Hands itching - started 1.5 days after shot -treatment: antihistamine - symptoms ongoing
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: Burning/stinging sensation on tongue, roof of mouth,back of throat - started 1 hour after shot - treatment: oral rinse - symptoms ongoing Nose bleeds- almost daily - started 8 hours after shot - treatment : applying pressure, naso gel, neosporin - symptoms ongoing Hands itching - started 1.5 days after shot -treatment: antihistamine - symptoms ongoing
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Depression, Hallucination, auditory, Mania
Clinical narrative: Psychosis and mania. Lack of sleep. Started at 9pm. Started having strange thoughts and started hearing noises. Felt like someone was in my house. Went to bed, continues hearing noises and having untrue thoughts. Continued all through the night. Eventually fell asleep at 4:30am. Woke up at 8:20am. Felt very depressed and continues to have psychosis and untrue thoughts. All day had a lack of energy, not hungry. After researching through website I saw psychosis and mania was a side effect of the vaccine. I have never felt these feelings before. I have never had psychosis before. After finding out this was a side effect. I talked to my wife about my untrue thoughts. I convince to feel a lack of energy and depressed, but realizing it?s a side effect helped with the psychosis. It?s still there, but I understand where it?s coming from.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Psychotic disorder, Sleep deficit, Thinking abnormal
Clinical narrative: Psychosis and mania. Lack of sleep. Started at 9pm. Started having strange thoughts and started hearing noises. Felt like someone was in my house. Went to bed, continues hearing noises and having untrue thoughts. Continued all through the night. Eventually fell asleep at 4:30am. Woke up at 8:20am. Felt very depressed and continues to have psychosis and untrue thoughts. All day had a lack of energy, not hungry. After researching through website I saw psychosis and mania was a side effect of the vaccine. I have never felt these feelings before. I have never had psychosis before. After finding out this was a side effect. I talked to my wife about my untrue thoughts. I convince to feel a lack of energy and depressed, but realizing it?s a side effect helped with the psychosis. It?s still there, but I understand where it?s coming from.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Shot was given on 3/25 at 3:15 pm.  Began to itch on 3/26 at night. Entire upper thigh is swollen, red, and itchy.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Endoscopy normal, Magnetic resonance imaging head, Nausea, Vomiting
Clinical narrative: Hours after, developed nausea and vomiting that has persisted since then
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time normal, Amnesia, Angiogram normal, Anticoagulant therapy, Blood cholesterol increased
Clinical narrative: New-Onset Hemiplegic Migraines with no prior history, right-sided arm and leg paralysis, right-sided facial droop, slurred speech, difficulty problem solving, short-term memory loss, weight gain  Migraines now 3-4 times a week Stroke like symptoms led to treatment for possible blood clots with Plavix and Aspirin
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Chest X-ray normal, Coagulation test normal, Computerised tomogram head normal, Computerised tomogram neck
Clinical narrative: New-Onset Hemiplegic Migraines with no prior history, right-sided arm and leg paralysis, right-sided facial droop, slurred speech, difficulty problem solving, short-term memory loss, weight gain  Migraines now 3-4 times a week Stroke like symptoms led to treatment for possible blood clots with Plavix and Aspirin
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cytogenetic analysis normal, Disturbance in attention, Dysarthria, Electrocardiogram ambulatory normal, Electrocardiogram normal
Clinical narrative: New-Onset Hemiplegic Migraines with no prior history, right-sided arm and leg paralysis, right-sided facial droop, slurred speech, difficulty problem solving, short-term memory loss, weight gain  Migraines now 3-4 times a week Stroke like symptoms led to treatment for possible blood clots with Plavix and Aspirin
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Full blood count normal, Hemiplegia, Hemiplegic migraine, International normalised ratio normal
Clinical narrative: New-Onset Hemiplegic Migraines with no prior history, right-sided arm and leg paralysis, right-sided facial droop, slurred speech, difficulty problem solving, short-term memory loss, weight gain  Migraines now 3-4 times a week Stroke like symptoms led to treatment for possible blood clots with Plavix and Aspirin
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Metabolic function test normal, Migraine, Monoplegia, Neurological symptom
Clinical narrative: New-Onset Hemiplegic Migraines with no prior history, right-sided arm and leg paralysis, right-sided facial droop, slurred speech, difficulty problem solving, short-term memory loss, weight gain  Migraines now 3-4 times a week Stroke like symptoms led to treatment for possible blood clots with Plavix and Aspirin
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast normal, Troponin normal, Weight increased
Clinical narrative: New-Onset Hemiplegic Migraines with no prior history, right-sided arm and leg paralysis, right-sided facial droop, slurred speech, difficulty problem solving, short-term memory loss, weight gain  Migraines now 3-4 times a week Stroke like symptoms led to treatment for possible blood clots with Plavix and Aspirin
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cold sweat, Contusion, Fatigue, Induration, Injection site erythema
Clinical narrative: Symptoms: muscle aches, swelling, redness, warmth, and pain in left arm; nausea , fatigue, cold sweats Onset: 3/24 day after vaccines Signs:  Warm, erythematous, indurated area from L proximal 2/3 of upper extremity (See pic) +tender to palpation Small area of bruising centrally
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site induration, Injection site pain, Injection site warmth, Myalgia, Nausea
Clinical narrative: Symptoms: muscle aches, swelling, redness, warmth, and pain in left arm; nausea , fatigue, cold sweats Onset: 3/24 day after vaccines Signs:  Warm, erythematous, indurated area from L proximal 2/3 of upper extremity (See pic) +tender to palpation Small area of bruising centrally
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: Symptoms: muscle aches, swelling, redness, warmth, and pain in left arm; nausea , fatigue, cold sweats Onset: 3/24 day after vaccines Signs:  Warm, erythematous, indurated area from L proximal 2/3 of upper extremity (See pic) +tender to palpation Small area of bruising centrally
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Malaise, Muscle tightness
Clinical narrative: Itchy, hot red arm around injection site almost all the way around my arm, started within 2 hours of injection, maybe less.    Malaise, but maybe because I took 25 mg Benadryl, then another 25 mg. about 4 hours later. I sleep all afternoon and evening off and on.  I have been extra achey all overand still have a hot red upper right arm around the injection site. My neck seems to be more tight and achey today as well, and I've had some nausea.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Neck pain, Pain, Somnolence
Clinical narrative: Itchy, hot red arm around injection site almost all the way around my arm, started within 2 hours of injection, maybe less.    Malaise, but maybe because I took 25 mg Benadryl, then another 25 mg. about 4 hours later. I sleep all afternoon and evening off and on.  I have been extra achey all overand still have a hot red upper right arm around the injection site. My neck seems to be more tight and achey today as well, and I've had some nausea.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Chills, Condition aggravated, Headache
Clinical narrative: Chills, headache, pain in arm, underarm and in right breast couldn't move  my  right arm. Had to leave work early that Thursday didn't return until Monday. Didn't go to the doctor or hospital.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Mobility decreased, Pain in extremity
Clinical narrative: Chills, headache, pain in arm, underarm and in right breast couldn't move  my  right arm. Had to leave work early that Thursday didn't return until Monday. Didn't go to the doctor or hospital.
Age: 18.0
Sex: U
Vaccine: FLUC4
Symptoms: Dyspnoea, Loss of consciousness, Muscle rigidity, Pallor, Seizure like phenomena
Clinical narrative: Pt passed out + was unconscious after the shot was administered. She appeared short of breath and her face ,color was very pale . she was not moving when we tried to consider putting her  on floor. She seemed to have rigid body & seizure like.  I administered 2 doses of epinephrine & a few min.  after second dose pt became conscious & paramedics took her to Hospital. *  Patient was very nervous about receiving her vaccination & brought her boy friend along for support. She stated she was very nervous, as she was planning to  receive a Moderna vaccine after the Flucelvax vaccine.  Sine she had the reaction to Flucelvax, she never received the Moderna vaccine that day.  *Patient urinated during the time she was unconscious.
Age: 18.0
Sex: U
Vaccine: FLUC4
Symptoms: Urinary incontinence
Clinical narrative: Pt passed out + was unconscious after the shot was administered. She appeared short of breath and her face ,color was very pale . she was not moving when we tried to consider putting her  on floor. She seemed to have rigid body & seizure like.  I administered 2 doses of epinephrine & a few min.  after second dose pt became conscious & paramedics took her to Hospital. *  Patient was very nervous about receiving her vaccination & brought her boy friend along for support. She stated she was very nervous, as she was planning to  receive a Moderna vaccine after the Flucelvax vaccine.  Sine she had the reaction to Flucelvax, she never received the Moderna vaccine that day.  *Patient urinated during the time she was unconscious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Blood test, Diarrhoea, Laboratory test
Clinical narrative: 3/23/22  "Felt weak but Got Better" 3/24/22  "Stomach pain, diarrhea"
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: 3/23/22  "Felt weak but Got Better" 3/24/22  "Stomach pain, diarrhea"
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram normal, Epistaxis, Fatigue, Haematochezia, Hypoaesthesia oral
Clinical narrative: Day 2:Woke up very Tired. Under side of arm vacinated Swollen. neck sTiff, Tingling in face. Later That day noticed bottom front Teeth, gum & lower part of Tongue numb. Slept most of 2 days.  Day 3:  Bloody nose, bloody stool, fever over 100. Teeth affected loose. Some numbness remained until Day 18. Even Today Teeth do not Feel normal. Some Tingling around heart. Have had  Echo, heart okay.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Loose tooth, Musculoskeletal stiffness, Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: Day 2:Woke up very Tired. Under side of arm vacinated Swollen. neck sTiff, Tingling in face. Later That day noticed bottom front Teeth, gum & lower part of Tongue numb. Slept most of 2 days.  Day 3:  Bloody nose, bloody stool, fever over 100. Teeth affected loose. Some numbness remained until Day 18. Even Today Teeth do not Feel normal. Some Tingling around heart. Have had  Echo, heart okay.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: Day 2:Woke up very Tired. Under side of arm vacinated Swollen. neck sTiff, Tingling in face. Later That day noticed bottom front Teeth, gum & lower part of Tongue numb. Slept most of 2 days.  Day 3:  Bloody nose, bloody stool, fever over 100. Teeth affected loose. Some numbness remained until Day 18. Even Today Teeth do not Feel normal. Some Tingling around heart. Have had  Echo, heart okay.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd Moderna given 7 days before the recommended time between the 1st & 2nd dose
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram abdomen, Computerised tomogram pelvis
Clinical narrative: L/eye pain started with in 5 days of second shot and she was dx w/iritis. Then developed right upper chest pain ~ 1 month later. Work up has found nothing. Brother also lost eye site and had head pain shortly after his vaccine as well
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Eye pain, Hepatobiliary scan, Iritis, Magnetic resonance imaging
Clinical narrative: L/eye pain started with in 5 days of second shot and she was dx w/iritis. Then developed right upper chest pain ~ 1 month later. Work up has found nothing. Brother also lost eye site and had head pain shortly after his vaccine as well
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oesophagogastroduodenoscopy, Ultrasound abdomen, Ultrasound pelvis
Clinical narrative: L/eye pain started with in 5 days of second shot and she was dx w/iritis. Then developed right upper chest pain ~ 1 month later. Work up has found nothing. Brother also lost eye site and had head pain shortly after his vaccine as well
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Sudden death
Clinical narrative: 2/22/2021- 1st COVID Vaccine, Pfizer lot #EN6203.  3/14/2021- 2nd Covid Vaccine, Pfizer lot #P6955S.   9/17/2021- Flu shot and Shingrix shot.  11/11/2021- 3rd COVID Vaccine, Pfizer lot #FH028.  11/14/2021- Found dead at home.   11/17/2021- Autopsy performed.  03/28/2022- Histology shows evidences of:                         A. Eosinophilic pericarditis                         B. Multi-focal peri-microvascular hemorrhages of the brain
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Cerebral haemorrhage, Death, Histology abnormal, Pericarditis
Clinical narrative: 2/22/2021- 1st COVID Vaccine, Pfizer lot #EN6203.  3/14/2021- 2nd Covid Vaccine, Pfizer lot #P6955S.   9/17/2021- Flu shot and Shingrix shot.  11/11/2021- 3rd COVID Vaccine, Pfizer lot #FH028.  11/14/2021- Found dead at home.   11/17/2021- Autopsy performed.  03/28/2022- Histology shows evidences of:                         A. Eosinophilic pericarditis                         B. Multi-focal peri-microvascular hemorrhages of the brain
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: 2/22/2021- 1st COVID Vaccine, Pfizer lot #EN6203.  3/14/2021- 2nd Covid Vaccine, Pfizer lot #P6955S.   9/17/2021- Flu shot and Shingrix shot.  11/11/2021- 3rd COVID Vaccine, Pfizer lot #FH028.  11/14/2021- Found dead at home.   11/17/2021- Autopsy performed.  03/28/2022- Histology shows evidences of:                         A. Eosinophilic pericarditis                         B. Multi-focal peri-microvascular hemorrhages of the brain
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Patient fainted/felt lightheaded after receiving first dose of Moderna. Patient within the 15 min observation time, and sitting in her chair in the observation area. She felt lightheaded, and ended up laying on the floor. 911 was called immediately. When the pharmacist got to the patient, she was alert, awake, knew her name, DOB and where she was. She stated she didn't eat before coming because she was nervous. 911 arrived. Patient's vitals checked and determined to be within normal limits (on all vitals). She did not hit her head or have concussion. She was released to her mother who was also in presence. She was not taken to hospital.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Rash
Clinical narrative: Hives 3 weeks after administration of Moderna vaccine
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives 3 weeks after administration of Moderna vaccine
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dehydration, Incorrect dose administered, Product preparation issue, Pyrexia, Urine output decreased
Clinical narrative: Patient presented to Clinic on 3/25/22 with Guardian for 2nd dose of Pfizer (Children's-5-11).  Nurse (LVN)  administered a 0.2 dose of undiluted orange cap Pfizer 5-11 vaccine to the patient.  Nurse failed to properly reconstitute vaccine prior to administration.  Patient was observed for 15 minutes per policy with no adverse reaction and nurse was unaware of the error at this time.  Nurse discovered the error at the end of day when waste was being evaluated from COVID vaccine vials and reported to (RN).  RN reported to Health Authority and called the child's parent to report error and advise to monitor for adverse effects or events.  Dr. engaged in peer to peer Consult with MD- Pediatric on call for the child's pediatric practice regarding the event.  Ped MD reported the mother reported vomiting and febrile condition of 106 degrees on the evening of 3/25 and he was seen in her office the morning of 3/26.  Child was experiencing no further side effects as of 3/28/22  and will follow in care with his regular pediatrician.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting projectile
Clinical narrative: Patient presented to Clinic on 3/25/22 with Guardian for 2nd dose of Pfizer (Children's-5-11).  Nurse (LVN)  administered a 0.2 dose of undiluted orange cap Pfizer 5-11 vaccine to the patient.  Nurse failed to properly reconstitute vaccine prior to administration.  Patient was observed for 15 minutes per policy with no adverse reaction and nurse was unaware of the error at this time.  Nurse discovered the error at the end of day when waste was being evaluated from COVID vaccine vials and reported to (RN).  RN reported to Health Authority and called the child's parent to report error and advise to monitor for adverse effects or events.  Dr. engaged in peer to peer Consult with MD- Pediatric on call for the child's pediatric practice regarding the event.  Ped MD reported the mother reported vomiting and febrile condition of 106 degrees on the evening of 3/25 and he was seen in her office the morning of 3/26.  Child was experiencing no further side effects as of 3/28/22  and will follow in care with his regular pediatrician.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue, Pyrexia, Vomiting
Clinical narrative: Patient presented to Clinic on 3/25/22 with Guardian for 2nd dose of Pfizer (Children's-5-11).  Nurse (LVN)  administered a 0.2 dose of undiluted orange cap Pfizer 5-11 vaccine to the patient.  Nurse failed to properly reconstitute vaccine prior to administration.  Patient was observed for 15 minutes per policy with no adverse reaction and nurse was unaware of the error at this time.  Nurse discovered the error at the end of day when waste was being evaluated from COVID vaccine vials and reported to (RN).  RN reported to Health Authority and called the child's parent to report error and advise to monitor for adverse effects or events.  Dr. engaged in peer to peer Consult with MD- Pediatric on call for the child's pediatric practice regarding the event.  Ped MD reported the mother reported vomiting and febrile condition of 106 degrees on the evening of 3/25 and he was seen in her office the morning of 3/26.  Child was experiencing no further side effects as of 3/28/22  and will follow in care with his regular pediatrician.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No other issues or concerns noted; a patient who received an expired dose of MMRII; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about the patient's concomitant medication, pertinent medical history and drug reactions/allergies was not reported.   On 21-MAR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) lot #T007235, expiration date 27-FEB-2022 (dose and route of administration were not provided) for prophylaxis (expired product administered). No other issues or concerns noted.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pyrexia
Clinical narrative: fever; small bumps around the injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd October 2020, 1 days after receiving Shingrix, the patient experienced fever and injection site swelling. On an unknown date, the outcome of the fever and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the fever and injection site swelling to be related to Shingrix.     Additional details reported were as follows: This case was reported by the patient. The patient received Shingrix in left arm. The patient developed a low-grade fever and small bumps around the injection site the evening she received the Shingrix vaccine.  The fever and small bumps were recovered about 5 days later.  The patient did not give permission to contact healthcare professional. The reporter did not consent to follow-up. For tolerance of 2nd dose refer case US2022AMR053479.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR053479:Same reporter
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Muscular weakness, Pain in extremity
Clinical narrative: arm was being blown up like a balloon, pain in arm; Redness from shoulder to elbow; weakness in left arm/ lack of strength in the left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 12th November 2021, 1 days after receiving Shingrix, the patient experienced pain in arm, erythema and weakness of arms. On an unknown date, the outcome of the pain in arm and weakness of arms were not recovered/not resolved and the outcome of the erythema was recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema and weakness of arms to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine intramuscularly into his left arm and when the injection was administered he felt like his arm was being blown up like a balloon. The next day he experienced pain in his arm, redness from his shoulder to his elbow and weakness in the left arm. The redness resolved after 1 and half weeks, however he was currently still experiencing soreness and lack of strength in the left arm. The reporter did not give consent to contact his HCP (health care professional) and he did not have an email. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the diluent portion was administered; Only the diluent portion was administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd March 2022, the patient received the 1st dose of Shingrix. On 23rd March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. Health care professional (HCP) did not had any patient demographic or vaccine details (lot, expiry date) at the time of call. Clinical pharmacist practitioner stated that only the diluent portion of Shingrix was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Death, Sudden death
Clinical narrative: Patient died on the same day she got the vaccine; This case was reported by a other health professional via call center representative and described the occurrence of sudden death in a 64-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number MH5BH, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included chronic kidney disease (had chronic kidney disease). Concurrent medical conditions included type ii diabetes mellitus.   On 9th October 2020, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 9th October 2020, less than a day after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced sudden death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the sudden death was fatal. The patient died on 9th October 2020. The reported cause of death was sudden death.   It was unknown if the reporter considered the sudden death to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The pharmacy technician reported that a patient received a dose of the 2020-2021 FluLaval, and the patient's husband reportedly sent an email stating that the patient (his wife) died on the same day. Thecertificate of death lists 15th April 2021 as the date of death. The cause of death was listed as natural. Other possible causes were listed as uncontrolled type II diabetes and chronic kidney disease.  The patient's husband reportedly asked for a copy of the prescribing information for the vaccine his wife received. The reporter consented to follow up. There was discrepancy in death date, on certificate of death it was 15th October 2021, but as death was occurred on 9th October 2020, hence death date captured as 9th October 2020 instead of 15th April 2021.; Reported Cause(s) of Death: Sudden death
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF-LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, administered on 24-MAR-2022 11:35 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2022, the patient experienced off-label use, and vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use and vaccine administered to patient of inappropriate age was not reported. This report was non-serious. This case, from the same reporter is linked to 20211052091 and 20211051934.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lacrimation increased, Rhinorrhoea, Sinusitis, Therapeutic response unexpected, Tooth abscess
Clinical narrative: SINUS INFECTION; DENTAL ABSCESSES ON THE UPPER LEFT SIDE AND LOWER RIGHT SIDE OF MOUTH; GREEN HUNKS CAME OUT FROM NOSE; IMPROVED BREATHING; WATERY EYES; RUNNY NOSE FOR WHOLE STRAIGHT DAY; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included: recurrent sinus problems, and cocaine abuse, and concurrent conditions included: smoker, non-alcohol user, chronic obstructive pulmonary disease (copd), and allergy to hives, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient had drug abuse or illicit drug use when was 19 year old. In 1996, the patient could only sleep on one side or could not breath. The patient had cocaine and was smoking marijuana due to childhood trauma. Currently it was drug use, not abuse, mainly smoking marijuana limited for fun. The patient have never been sick in life, never hospitalized, had a biopsy once but nothing came of it. The patient has been on antibiotics for years for sinus infection, abusive of antibiotics which would help for only 3 days then gets difficult to breath again. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 23-JUL-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2022, the patient experienced watery eyes, and runny nose for whole straight day. On an unspecified date, the patient experienced sinus infection, dental abscesses on the upper left side and lower right side of mouth, green hunks came out from nose, and improved breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sinus infection, and dental abscesses on the upper left side and lower right side of mouth, and watery eyes, and runny nose for whole straight day on 04-MAR-2022, and the outcome of improved breathing and green hunks came out from nose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: suffering and in a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (suffering and in a lot of pain) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (suffering and in a lot of pain). At the time of the report, PAIN (suffering and in a lot of pain) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant drug was reported. No Treatment medications were reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered was the Booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered was the Booster dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 009C21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered was the Booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered was the Booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications was reported.  The patients didn´t have any allergies, acute or chronic illnesses at the time of vaccination, and no other vaccines were administered within 1 month prior to Moderna COVID-19 Vaccine. The patients were not experiencing any symptoms after receiving the expired dose.   This case was linked to MOD-2022-521623, MOD-2022-521490 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose given 29Mar2021, 2nd dose given on 09May2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given 29Mar2021, 2nd dose given on 09May2021) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis (Was diagnosed 10-15 years).  Concomitant products included RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given 29Mar2021, 2nd dose given on 09May2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given 29Mar2021, 2nd dose given on 09May2021) outcome was unknown.      It was reported that patient has psoriasis (diagnosed 10-15 years) ago and said that was considered as an immunocompromised state. Patient denied any Covid-19 infection prior to and after getting the vaccine. No treatment details were reported.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: L15-month-old patient who was given an expired DAPTACE with no reported adverse event; Initial information received on 14-Mar-2022 regarding an unsolicited valid non-serious case received from  other health professional.  This case involves a 15 months old female patient who was given an expired daptace with no reported adverse event while receiving vaccine Diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza vaccine inact split 4v (Fluzone quadrivalent) for Prophylactic vaccination.  On 12-Mar-2022, the patient received a dose of 0.5 ML suspect Diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (Strength, expiry date: unknown) lot C5706EA via intramuscular route in unknown administration site for immunization.  On an unknown date the 15-month-old patient who was given an expired daptace with no reported adverse event (expired product administered) (latency : unknown) following the administration of Diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event l15-month-old patient who was given an expired daptace with no reported adverse event.     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 guidelines. 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: 1.58
Sex: F
Vaccine: HIBV, MNQ
Symptoms: Accidental exposure to product, Medication error, No adverse event, Wrong product administered
Clinical narrative: a 19 month old patient inadvertently received MENACTRA instead of HIB vaccinewith no adverse event; a 19 month old patient inadvertently received MENACTRA instead of HIB vaccine with no adverse event; Initial information received on 16-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 months old female patient who experienced a 19 month old patient inadvertently received menactra instead of hib vaccine with no adverse event while receiving vaccines HIB (PRP/T) vaccine [ACT-HIB] and Meningococcal a-c-y-w135 (D CONJ) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine (pneumocin [pneumococcal vaccine]), diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap), measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (proquad), hepatitis a vaccine (hepatitis a) and influenza vaccine (flu) all for immunisation.  On 15-Mar-2022, the patient received a dose of suspect Meningococcal a-c-y-w135 (D CONJ) vaccine and HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  On 15-MAR-2022 (latency: same day) the patient developed a non-serious event a 19 month old patient inadvertently received menactra instead of hib vaccine with no adverse event  (accidental exposure to product) (wrong product administered) following the administration of Meningococcal a-c-y-w135 (D CONJ) vaccine and HIB (prp/t) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events (accidental exposure to product) (wrong product administered).  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 guidelines. 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: 4.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Medication error, Product use issue
Clinical narrative: patient has received an IPOL vaccination from the opened multi-dose vial since the first excursion on 10JAN2021 with no AE; Initial information received on 17-Mar-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 years old male patient who has received an ipol vaccination from the opened multi-dose vial since the first excursion on 10jan2021 with no ae while receiving vaccine IPV (Vero) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine, varicella zoster vaccine (measles vaccine;mumps vaccine;rubella vaccine;varicella zoster vaccine).  On 10-Mar-2022, the patient received a dose of suspect IPV (VERO) Suspension for injection (lot T1E871M; expiry date: 10-OCT-2022; strength: unknown) at a dose of 0.5 ml once total via intramuscular route in right leg as prophylactic vaccination.  On 10-MAR-2022, the patient has received an IPV (VERO) vaccination from  the opened multi-dose vial since the first excursion on 10-Jan-2021 with no AE (product use issue) (latency: same day).  It was reported that, doctorstated that the IPOL was first punctured on 17-Aug-2021 and also, doctor asked if the IPOL that was given should be re-administered because it was non-viable.  Action taken: not applicable.  At time of reporting, the outcome was unknown for the event.  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.
Sex: U
Vaccine: IPV
Symptoms: Intentional product misuse, No adverse event
Clinical narrative: vial contains 10 doses however she has been using 1 or 2 at most before she has to throw the whole bottle of 10 doses away with no reported adverse event; Initial information received on 17-Mar-2022 regarding an unsolicited valid non-serious case was received from a pharmacist.  This case involves an unknown age and unknown gender patient who had been using 1 or 2 at most (vial contained 10 doses), before the pharmacist had to throw the whole bottle of 10 doses away with no reported adverse event while receiving vaccine ipv (vero) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect IPV (VERO) (lot number and expiry date not reported) via unknown route in unknown administration site as prophylactic vaccination.  It was reported that the vial contained 10 doses however she had been using 1 or 2 at most before she had to throw the whole bottle of 10 doses away with no reported adverse event (intentional product misuse) (unknown latency) following the administration of IPV (VERO). It was because when the pharmacist looked it up it said to discard the vial 28 days after opening. She stated that she was informed by another pharmacist that it should last longer and she needed to confirm this. She stated that if this is the case she did not know how she could keep ordering one bottle and just dispensing one dose. After the information was provided to her she stated that she wishes she had known this sooner because this was the 4th bottle she had thrown away. She stated that she was torn ordering the vial for a patient over and over and that she did a lot of vaccines.   Action taken with poliomyelitis vaccine (inactivated) (ipol) was not applicable.  It was not reported if the patient received a corrective treatment for the event (vial contains 10 doses however she has been using 1 or 2 at most before she has to throw the whole bottle of 10 doses away with no reported adverse event).  At time of reporting, the outcome was Unknown for the event vial contains 10 doses however she has been using 1 or 2 at most before she has to throw the whole bottle of 10 doses away with no reported adverse event.
Age: 0.17
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a staff member administered FLUZONE QIV NP to a 10 week old patient instead of Prevnar with no reported adverse event; FLUZONE QIV NP is not approved for use in patients less than 6 months old; and admintered FLUZONE QIV NP to 10 week old patients with no reported adverse event; Initial information received on 18-Mar-2022 regarding an unsolicited valid  non-serious case received from a non-healthcare professional.  This case involves a 2 months old and unknown gender patient who was administered Influenza quadrivaL A-B vaccine [Fluzone QIV] instead of Prevnar which is not approved for use in patients less than 6 months old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza quadrivaL A-B vaccine (with an unknown formulation, strength, dose and route) (lot number: UT7407AM and expiry date: 30-Jun-2022) in unknown administration site for prophylactic immunization.  On an unknown date the patient was administered Influenza quadrivaL A-B vaccine instead of Prevnar with no reported adverse event (wrong product administered) and Influenza quadrivaL A-B vaccine is not approved for use in patients less than 6 months old with no reported adverse event (product use issue).  Action taken was not applicable.  Outcome: Unknown    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: 2.0
Sex: U
Vaccine: HEPA, HIBV, IPV, PNC, VARCEL
Symptoms: Expired product administered, Medication error, Vaccination site erythema
Clinical narrative: redness on the left thigh; used an expired dose on a patient of poliovirus; Initial information received on 18-Mar-2022 and then on 21-Mar-2022 regarding an unsolicited valid non-serious case received by a health professional via call center.  This case involves a 2 years old unknown gender patient who experienced redness on the left thigh while receiving vaccine Poliomyelitis Vaccine (Inactivated) [IPOL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) for Immunisation; Hib Vaccine (HIB) for Immunisation; Varicella Zoster Vaccine (Varicella Vaccine) for Immunisation; and Hepatitis A Vaccine (Hepatitis A) for Immunisation.  On 18-Mar-2022, the patient received 0.5 mL of Poliomyelitis Vaccine (Inactivated) suspension for injection (strength: unknown; lot R1F973M and expiry date:03-Oct-2021) via intramuscular route in the left thigh for immunization.  On 18-MAR-2022 (Latency: same day), the patient developed redness on the left thigh (vaccination site erythema) after the HCP used an expired dose on a patient of poliovirus (expired product administered).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  Event outcome: Not Recovered / Not Resolved for the event redness on the left thigh.  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.