chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test, Toxicologic test, Urine analysis, Vision blurred
Clinical narrative: On Sept 26th, had a sudden onset of neurological symptoms.  She experienced blurred vision, speech difficulty, an overall "out of it" feeling, and muscle tics in her head, arms and legs.  We took her to the ER and tests all came back negative.  Her symptoms began to resolve after 6-8 hrs with the exception of her muscle tics which continued.  Over the next couple month, she experienced 2 more mental episodes where her speech and behavior were affected, and the twitching worsened.  Pediatric neurology referral initially diagnosed her with PANDAS but with no active strep infection, possibly PANS related to some other infection.  Repeat blood work did not show any active infection, however.  It was then hypothesized that hte COVID vaccine, which she had received the month prior might have been a trigger to her immune system, and somehow was mimicking the PANDAS symptoms.  At this time, she is still experienced muscle tics, though not as frequently.
Age: 57.0
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever 101.4, chills, muscle ache, headache, fatigue. Treated with Acetaminophen.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Computerised tomogram, Death, Injection site mass, Positron emission tomogram
Clinical narrative: 9 months after the vaccine my wife discovered a tumor the size of a walnut on her right tricep, at virtually the same location where the vaccine needle entered her muscle. Within 3 months it had grown to the size of mango, and by November it had grown to three pounds. On November 1st, 2022 the surgeon removed the tumor. It took her life February 18th, 2023 at 9:30pm.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tumour excision, Ultrasound scan
Clinical narrative: 9 months after the vaccine my wife discovered a tumor the size of a walnut on her right tricep, at virtually the same location where the vaccine needle entered her muscle. Within 3 months it had grown to the size of mango, and by November it had grown to three pounds. On November 1st, 2022 the surgeon removed the tumor. It took her life February 18th, 2023 at 9:30pm.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest X-ray abnormal, Computerised tomogram, Echocardiogram abnormal, Laboratory test, Myopericarditis
Clinical narrative: AE: Myopericarditis, Treatment: IV & Oral Steroid, treatment: in progress, Outcome: TBD
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Troponin
Clinical narrative: AE: Myopericarditis, Treatment: IV & Oral Steroid, treatment: in progress, Outcome: TBD
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pruritus, Injection site rash, Injection site reaction, Rash erythematous, Urticaria
Clinical narrative: Two days after receiving the meningococcal vaccine, my son experienced a hives type of rash circling the injection site on his left deltoid. The area was itchy and  white welts swelled up against a red rash on the skin. It started off as a small hive on one side of the arm then it spread all around the area of the injection site within an hour. I did not have an allergy cream so I used cortizone 10 cream on the rash. I applied it the evening it appeared and thankfully it was gone by morning.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Diarrhoea, Fibrin D dimer increased, Full blood count normal, Metabolic function test normal
Clinical narrative: body aches, nausea, vomiting, diarrhea
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pregnancy test negative, Pulmonary embolism, Troponin normal
Clinical narrative: body aches, nausea, vomiting, diarrhea
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: body aches, nausea, vomiting, diarrhea
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given 0.2ML of the 30mcg formula instead of 0.2ML of the 10mcg formula.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT WAS GIVEB 0.2ML OF THE 30MCG FORMULA INSTEAD 0F 0.2ML OF THE 10MCG FORMULA,
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiparesis, Sensory loss
Clinical narrative: Mild R hemiparesis and decreased sensation starting within 15 min post vaccine. Had this after previous COVID vaccines also, severe the 1st time and was off work x a month.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Blood electrolytes normal, Blood glucose normal, Dizziness, Dyspnoea
Clinical narrative: J and J vaccine 7 days of HA, tiredness and swollen lymph nodes in neck and under left arm with generalized alopecia for several week, given in April 2021. Moderna vaccine 10/28/21: HA, fatigue, hair lossmus and nerve pain in both feet. tinnitus, shortness of breath, frequent urination and waking in night to urinate, dizziness, light headed. All continuing until now.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Laboratory test normal, Liver function test normal, Lymphadenopathy
Clinical narrative: J and J vaccine 7 days of HA, tiredness and swollen lymph nodes in neck and under left arm with generalized alopecia for several week, given in April 2021. Moderna vaccine 10/28/21: HA, fatigue, hair lossmus and nerve pain in both feet. tinnitus, shortness of breath, frequent urination and waking in night to urinate, dizziness, light headed. All continuing until now.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test normal, Middle insomnia, Neuralgia, Pollakiuria, Renal function test normal
Clinical narrative: J and J vaccine 7 days of HA, tiredness and swollen lymph nodes in neck and under left arm with generalized alopecia for several week, given in April 2021. Moderna vaccine 10/28/21: HA, fatigue, hair lossmus and nerve pain in both feet. tinnitus, shortness of breath, frequent urination and waking in night to urinate, dizziness, light headed. All continuing until now.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroid function test normal, Tinnitus
Clinical narrative: J and J vaccine 7 days of HA, tiredness and swollen lymph nodes in neck and under left arm with generalized alopecia for several week, given in April 2021. Moderna vaccine 10/28/21: HA, fatigue, hair lossmus and nerve pain in both feet. tinnitus, shortness of breath, frequent urination and waking in night to urinate, dizziness, light headed. All continuing until now.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF 0.2ML OF THE 10MCG FORMULA,
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF 0.2ML OF THE 10MCG FORMULA,
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF 0.2ML OF THE 10MCG FORMULA,
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF 0.2ML OF THE 10MCG FORMULA,
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Malaise, Pruritus, Urticaria
Clinical narrative: Hives reported on both forearms including pruritis; Denies any shortness of breath; Has malaise and headache and slight cough; Patient is planning to take Diphenhydramine 50 mg every 6 hours until symptoms subside.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given 0.2ML of the 30 mcg formula instead of 0.2ML of the 10mcg formula.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given 0.2ML of the 30mcg formula instead of 0.2ML of the 10mcg formula.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INTEAD OF 0.2ML OF THE 10MCG FORMULA,
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF0.2ML OF THE 10MCG FORMULA,
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF O.2ML OF THE 10MCG FORMULA,
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF 0.2ML OF THE 10MCG FORMULA.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF 0.2ML OF THE 10MCG FORMULA,
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, redness, and warmth at injection site  Day 1 -10 and ongoing  Headache and increased fatigue day 2-9  Hard bump at injection site, Day 1-10 and ongoing
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth
Clinical narrative: Pain, swelling, redness, and warmth at injection site  Day 1 -10 and ongoing  Headache and increased fatigue day 2-9  Hard bump at injection site, Day 1-10 and ongoing
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MENB, MNQ
Symptoms: C-reactive protein increased, Chest discomfort, Computerised tomogram thorax normal, Dyspnoea, Echocardiogram
Clinical narrative: Per mother pt received Meningitis and Meningitis B vaccines on 3/9/2023. The following day she felt tired and then short of breath with heart racing and chest discomfort.  She presented  to the EC and was found to have elevated D  dimer and elevated but indeterminate troponin.  She also has elevated sed rate and CRP.  She is currently admitted in stable condition
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MENB, MNQ
Symptoms: Electrocardiogram, Fatigue, Fibrin D dimer increased, Palpitations, Red blood cell sedimentation rate increased
Clinical narrative: Per mother pt received Meningitis and Meningitis B vaccines on 3/9/2023. The following day she felt tired and then short of breath with heart racing and chest discomfort.  She presented  to the EC and was found to have elevated D  dimer and elevated but indeterminate troponin.  She also has elevated sed rate and CRP.  She is currently admitted in stable condition
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MENB, MNQ
Symptoms: Troponin increased
Clinical narrative: Per mother pt received Meningitis and Meningitis B vaccines on 3/9/2023. The following day she felt tired and then short of breath with heart racing and chest discomfort.  She presented  to the EC and was found to have elevated D  dimer and elevated but indeterminate troponin.  She also has elevated sed rate and CRP.  She is currently admitted in stable condition
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MENB, MNQ
Symptoms: Arthralgia, Blood test, C-reactive protein increased, Chest discomfort, Chills
Clinical narrative: Per mother pt received Meningitis and Meningitis B vaccines on 3/9/2023. The following day she felt tired and then short of breath with heart racing and chest discomfort.  She presented  to the EC and was found to have elevated D  dimer and elevated but indeterminate troponin.  She also has elevated sed rate and CRP.  She is currently admitted in stable condition
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MENB, MNQ
Symptoms: Computerised tomogram normal, Drug screen negative, Dyspnoea, Dyspnoea at rest, Dysstasia
Clinical narrative: Per mother pt received Meningitis and Meningitis B vaccines on 3/9/2023. The following day she felt tired and then short of breath with heart racing and chest discomfort.  She presented  to the EC and was found to have elevated D  dimer and elevated but indeterminate troponin.  She also has elevated sed rate and CRP.  She is currently admitted in stable condition
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MENB, MNQ
Symptoms: Echocardiogram, Electrocardiogram normal, Erythema, Fibrin D dimer, Full blood count normal
Clinical narrative: Per mother pt received Meningitis and Meningitis B vaccines on 3/9/2023. The following day she felt tired and then short of breath with heart racing and chest discomfort.  She presented  to the EC and was found to have elevated D  dimer and elevated but indeterminate troponin.  She also has elevated sed rate and CRP.  She is currently admitted in stable condition
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MENB, MNQ
Symptoms: Metabolic function test normal, Nausea, Pain in extremity, Red blood cell sedimentation rate increased, Swelling
Clinical narrative: Per mother pt received Meningitis and Meningitis B vaccines on 3/9/2023. The following day she felt tired and then short of breath with heart racing and chest discomfort.  She presented  to the EC and was found to have elevated D  dimer and elevated but indeterminate troponin.  She also has elevated sed rate and CRP.  She is currently admitted in stable condition
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Lethargy, Pyrexia
Clinical narrative: Headache, lethargy, fever, chills and sore injection site from about 6 hours post injection to about 60 hours post injection
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Condition aggravated, Flushing, Hyperhidrosis, Presyncope, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt had vasovagal episode after vaccinations. Cold compresses applied to pt back and neck. Vital signs stable.  Pt reports history of fainting spells when he had procedures in past. Pt placed in recovery position with feet elevated and stable for discharge after being given some glucose and recheck of vitals. Pt ambulatory to exit in no acute distress.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt had vasovagal episode after vaccinations. Cold compresses applied to pt back and neck. Vital signs stable.  Pt reports history of fainting spells when he had procedures in past. Pt placed in recovery position with feet elevated and stable for discharge after being given some glucose and recheck of vitals. Pt ambulatory to exit in no acute distress.
Age: 74.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Pt came into pharmacy march 4 2023 complaining of pain at injection site from shot given in september.  Had appt with primary care Dr. referred to orthopaedic md pt would like follow up
Age: 75.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Gave pt ice pack, symptoms significantly improved after apx 15 min.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Dizziness, Dyspnoea, Ear pain, Eye swelling
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: shortness of breath, pain in neck and back head, side face, ear all left sided-Mild, Systemic: Headache-Mild, Additional Details: left sided pressure and pain from neck to top of forehead on left side, side of administration.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Head discomfort, Headache, Hypersensitivity, Mouth swelling
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: shortness of breath, pain in neck and back head, side face, ear all left sided-Mild, Systemic: Headache-Mild, Additional Details: left sided pressure and pain from neck to top of forehead on left side, side of administration.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal discomfort, Neck pain, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: shortness of breath, pain in neck and back head, side face, ear all left sided-Mild, Systemic: Headache-Mild, Additional Details: left sided pressure and pain from neck to top of forehead on left side, side of administration.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site pain, Pyrexia
Clinical narrative: After 8 hours nothing but sore arm at injection site which I could relieve most soreness by moving arm a lot.  At 10 hours I was very tired and went to bed early (8pm vice 10pm normal bedtime).  At 13 hours I got up to take 1st dose of tylenol and was very chilled, shivering so violently I could not open the vacuum packed seal.  Day 2 I had low grade, 100.5, fever with chills, sweats back and forth. Today, Day 3 I am feeling 100% after sweating out fever overnight.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported. Patient received a second Moderna bivalent booster four months after his original bivalent booster.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered
Clinical narrative: When performing the vaccine count it was noted there was 1 more vial of the live virus vial than the diluent syringe.  Three patients have received doses so it is unclear if this patient received the correct dose.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Unevaluable event
Clinical narrative: When performing the vaccine count it was noted there was 1 more vial of the live virus vial than the diluent syringe.  Three patients have received doses so it is unclear if this patient received the correct dose.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Retinal vein occlusion, Surgery
Clinical narrative: Retinal venous occlusion
Age: 0.25
Sex: M
Vaccine: RV1
Symptoms: Incorrect dose administered
Clinical narrative: When performing the vaccine count it was noted there was 1 more vial of the live virus vial than the diluent syringe.  Three patients have received doses so it is unclear if this patient received the correct dose.
Age: 65.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Injection site erythema
Clinical narrative: REDNESS ON INJECTION ARM 6 DAYS POST VACCINATION
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Nocturia
Clinical narrative: pt reports having "tingling that started in left hand, progressed up to left arm and face, then started right hand and arm to face, and felt difficulty with speaking in addition to headache. it felt like i was coming off novacaine and i was able to speak but i felt like i was a robot speaking and had to think about it. The tingling and difficulty speaking lasted about 30min, i took a hot bath cause arm was so sore and head hurt, and went to bed. Did not sleep well due to headach and had to urinate all night long. i was exhausted next day. Today I still feel slight decreased feeling around mouth, otherwise feel back to normal." "I also had shivers with elevated HR by 20 bpm abve rhr all night. "
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Poor quality sleep, Sensory loss, Speech disorder
Clinical narrative: pt reports having "tingling that started in left hand, progressed up to left arm and face, then started right hand and arm to face, and felt difficulty with speaking in addition to headache. it felt like i was coming off novacaine and i was able to speak but i felt like i was a robot speaking and had to think about it. The tingling and difficulty speaking lasted about 30min, i took a hot bath cause arm was so sore and head hurt, and went to bed. Did not sleep well due to headach and had to urinate all night long. i was exhausted next day. Today I still feel slight decreased feeling around mouth, otherwise feel back to normal." "I also had shivers with elevated HR by 20 bpm abve rhr all night. "
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Unable to reach patient upon follow up
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: Headache, Muscle aches, nausea, chills and patient has been taking acetaminophen 500mg  2 q12h and then ibuprofen 200mg 2 q12h
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Fatigue, Pain, Pyrexia, Skin warm
Clinical narrative: Patient with a large local area of redness and swelling.  3 x 7 cm anterior upper right thigh.  Patient was fatigue and achy with low grade fever 1 day prior.  At 48 hours, less redness, but swelling significant with area hot to touch.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Swelling
Clinical narrative: Patient with a large local area of redness and swelling.  3 x 7 cm anterior upper right thigh.  Patient was fatigue and achy with low grade fever 1 day prior.  At 48 hours, less redness, but swelling significant with area hot to touch.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Affective disorder, Arthralgia, Asthma, Blood pressure increased, Blood test normal
Clinical narrative: Severe Physical Fatigue/ Mind Fog/Cognitive Impairment, Worsening Bronchial Asthma, Worsening Pain from neck, back, and shoulder injuries diagnosed by Dr., loss of sleep and worsening mood disorder from chronic pain. Also, effects of long term covid 19 have made adverse effects worse with increase in severe dizziness (head trauma and elevated blood pressure from chronic pain), been on going now for over 18 months
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Cognitive disorder, Condition aggravated, Dizziness, Fatigue
Clinical narrative: Severe Physical Fatigue/ Mind Fog/Cognitive Impairment, Worsening Bronchial Asthma, Worsening Pain from neck, back, and shoulder injuries diagnosed by Dr., loss of sleep and worsening mood disorder from chronic pain. Also, effects of long term covid 19 have made adverse effects worse with increase in severe dizziness (head trauma and elevated blood pressure from chronic pain), been on going now for over 18 months
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Neck pain, Pain, Post-acute COVID-19 syndrome
Clinical narrative: Severe Physical Fatigue/ Mind Fog/Cognitive Impairment, Worsening Bronchial Asthma, Worsening Pain from neck, back, and shoulder injuries diagnosed by Dr., loss of sleep and worsening mood disorder from chronic pain. Also, effects of long term covid 19 have made adverse effects worse with increase in severe dizziness (head trauma and elevated blood pressure from chronic pain), been on going now for over 18 months
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Migraine, Palpitations
Clinical narrative: Onset of vertigo and migraine, racing heart rate.  This lasted for approximately six weeks
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Migraine, Palpitations, Vaccine positive rechallenge, Vertigo
Clinical narrative: Onset of vertigo and migraine with racing heartbeat, which lasted about 12 weeks
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Migraine, Palpitations, Tinnitus, Vertigo
Clinical narrative: Onset of vertigo, migraines, tinnitus, and racing heartbeat
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: patient hospitalized.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Unevaluable event
Clinical narrative: patient hospitalized
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: patient hospitalized
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Received vaccine that had been past spoilage date
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient already received Moderna bivalent last year but wasn't documented in his covid vaccine card. He received another Moderna bivalent booster today by vaccinator. Vaccinator wasn't able to check on site until after due to slow wifi (in the basement). Patient was monitored for 30 min, Vital signs stable, NO ADVERSE REACTIONS noted.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: Hospitalized on 03/07/023 with severe SOB, remains on oxygen in hospital.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Accidentally used vaccine after refrigeration spoilage date
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Accidentally used vaccine after refrigeration spoilage date
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Accidentally used vaccine after refrigeration spoilage date
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Biopsy brain abnormal, Brain fog, Central nervous system lymphoma, Condition aggravated, Confusional state
Clinical narrative: A flare-up of sacroilitis 1 week after the 3rd booster. 4cm right frontal lobe  Primary CNS lymphoma diagnosed 2/1/22 Symptoms of brain fog, confusion, and difficulty concentrating started mid-January 2022
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Disturbance in attention, Sacroiliitis
Clinical narrative: A flare-up of sacroilitis 1 week after the 3rd booster. 4cm right frontal lobe  Primary CNS lymphoma diagnosed 2/1/22 Symptoms of brain fog, confusion, and difficulty concentrating started mid-January 2022
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Accidentally used vaccine after refrigeration spoilage date
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Biopsy, Blood test abnormal, Bronchoscopy, Computerised tomogram
Clinical narrative: Rapid onset stomach cancer with metastases to peritoneal cavity, lung, lymph, pancreas and colon resulting in death.  Presented with pancreatitis.  Stomach ache in early November 2022 led to concerning bloodwork, which led to hospitalization, which led to many diagnostic tests, which eventually showed rare and aggressive stomach cancer with many metastases.  Immunotherapy was attempted but ineffective, possibly exacerbated the issue.  This was the first of three Pfizer covid shots over the course of nine months.  Illness onset occurred approximately 13 months after the last shot.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Endoscopy, Intestinal metastasis, Laboratory test abnormal, Magnetic resonance imaging, Metastases to lung
Clinical narrative: Rapid onset stomach cancer with metastases to peritoneal cavity, lung, lymph, pancreas and colon resulting in death.  Presented with pancreatitis.  Stomach ache in early November 2022 led to concerning bloodwork, which led to hospitalization, which led to many diagnostic tests, which eventually showed rare and aggressive stomach cancer with many metastases.  Immunotherapy was attempted but ineffective, possibly exacerbated the issue.  This was the first of three Pfizer covid shots over the course of nine months.  Illness onset occurred approximately 13 months after the last shot.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Metastases to lymph nodes, Metastases to pancreas, Metastases to peritoneum, Metastatic gastric cancer, Pancreatitis
Clinical narrative: Rapid onset stomach cancer with metastases to peritoneal cavity, lung, lymph, pancreas and colon resulting in death.  Presented with pancreatitis.  Stomach ache in early November 2022 led to concerning bloodwork, which led to hospitalization, which led to many diagnostic tests, which eventually showed rare and aggressive stomach cancer with many metastases.  Immunotherapy was attempted but ineffective, possibly exacerbated the issue.  This was the first of three Pfizer covid shots over the course of nine months.  Illness onset occurred approximately 13 months after the last shot.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Positron emission tomogram
Clinical narrative: Rapid onset stomach cancer with metastases to peritoneal cavity, lung, lymph, pancreas and colon resulting in death.  Presented with pancreatitis.  Stomach ache in early November 2022 led to concerning bloodwork, which led to hospitalization, which led to many diagnostic tests, which eventually showed rare and aggressive stomach cancer with many metastases.  Immunotherapy was attempted but ineffective, possibly exacerbated the issue.  This was the first of three Pfizer covid shots over the course of nine months.  Illness onset occurred approximately 13 months after the last shot.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Redness around injection site, itching
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Accidentally used vaccine after refrigeration spoilage date
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine lasted about 7 days
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Accidentally used vaccine after refrigeration spoilage date
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriogram coronary abnormal, Bundle branch block left, Cardiac failure congestive, Cardiac imaging procedure abnormal, Cardiomyopathy
Clinical narrative: sudden onset cardiomyopathy with EF 22% congestive heart failure in patient iwht no cardiac disease. normal cath, MRI showed myocarditis
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Catheterisation cardiac normal, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram abnormal, Laboratory test normal
Clinical narrative: sudden onset cardiomyopathy with EF 22% congestive heart failure in patient iwht no cardiac disease. normal cath, MRI showed myocarditis
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial bridging, Myocarditis
Clinical narrative: sudden onset cardiomyopathy with EF 22% congestive heart failure in patient iwht no cardiac disease. normal cath, MRI showed myocarditis
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Photopsia, Vision blurred, Visual impairment
Clinical narrative: I awakened the morning after the vaccine with blurry vision , flashing and a black spot with peppery background in my field of vision in my left eye.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, FLUN4, PNC13, RV1, DTPPVHBHPB, FLUN4, PNC13, RV1
Symptoms: Circumstance or information capable of leading to medication error, Incorrect product formulation administered
Clinical narrative: Also discussed administering her initial Pfizer COVID19 vaccine. Inadvertently ordered a Pfizer 6month to 4 year bivalent SARS-COV-2 vaccine and this was administered as the first dose in her primary series.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site reaction, Rash maculo-papular, Vaccination site swelling
Clinical narrative: Redness swelling and rash (maculopapular) at site of vaccine
Age: 5.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Gave a 5-11 bivalent COVID vaccine, when patient was supposed to receive a COVID primary series dose 5-11.  No adverse reactions noted. Provider sent a message to patient's parent as follows:  I did find guidance of what to do for the second dose of COVID vaccine if bivalent was given for first dose.  They recommend monovalent be given.  Below is the link to the CDC guidance.  You can schedule the second dose at your convenience with us or a local pharmacy.      Per CDC "If a bivalent Pfizer-BioNTech vaccine is administered in error for a primary series dose: Do not repeat the dose. The primary and booster dosages are the same; the bivalent dose can be counted as a primary series dose. Continue with the recommended vaccination schedule (i.e., complete the primary series with a monovalent Pfizer-BioNTech vaccine, then administer a bivalent booster dose at least 2 months after completion of the primary series)."
Sex: U
Vaccine: HEP, HEP
Symptoms: Unevaluable event
Clinical narrative: No additional AE reported.; Office manager reported patient was accidently administered an expired dose of RECOMBIVAX HB on Feb 24, 2023.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 24-FEB-2023, the patient was accidently administered an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, once, lot #U019135, expiration date: 22-NOV-2022 for prophylaxis (strength and route of administration were not provided) (expired product administered). This vaccine had no prior temperature excursions. No further information was provided and no additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: HEP, HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Office manager reported patient was accidently administered an expired dose of RECOMBIVAX HB on Feb 24, 2023.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 24-FEB-2023, the patient was accidently administered an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, once, lot #U019135, expiration date: 22-NOV-2022 for prophylaxis (strength and route of administration were not provided) (expired product administered). This vaccine had no prior temperature excursions. No further information was provided and no additional adverse event (AE) was reported (no adverse event).
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blindness, Blood test, Burning sensation, Computerised tomogram
Clinical narrative: Within 2 weeks and have not stopped.  Numbness in legs, pain in legs, pins and needles in legs, burning in legs, pain in lower back, pain in spine, severe headaches, headaches behind eyes, pins and needles in face, blurry vision, temporary loss of vision, jaw pain, locking fingers, unable to stand up, unable to walk, unable to run.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Electroencephalogram, Eye pain, Gait inability, Headache
Clinical narrative: Within 2 weeks and have not stopped.  Numbness in legs, pain in legs, pins and needles in legs, burning in legs, pain in lower back, pain in spine, severe headaches, headaches behind eyes, pins and needles in face, blurry vision, temporary loss of vision, jaw pain, locking fingers, unable to stand up, unable to walk, unable to run.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Pain in jaw, Paraesthesia, Scan brain
Clinical narrative: Within 2 weeks and have not stopped.  Numbness in legs, pain in legs, pins and needles in legs, burning in legs, pain in lower back, pain in spine, severe headaches, headaches behind eyes, pins and needles in face, blurry vision, temporary loss of vision, jaw pain, locking fingers, unable to stand up, unable to walk, unable to run.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal pain, Trigger finger, Vision blurred, X-ray
Clinical narrative: Within 2 weeks and have not stopped.  Numbness in legs, pain in legs, pins and needles in legs, burning in legs, pain in lower back, pain in spine, severe headaches, headaches behind eyes, pins and needles in face, blurry vision, temporary loss of vision, jaw pain, locking fingers, unable to stand up, unable to walk, unable to run.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: RESIDENT PASSED ON 03/10/2023.  RESDIENT WAS UNDER HOSPICE CARE BUT HAD EXPRESSED THAT HE WANTED THE VACCINE BECAUSE HE WAS IN A LONG TERM FACILITY.
Age: 36.0
Sex: M
Vaccine: DT
Symptoms: Arthralgia, Bone pain, Hypoaesthesia, Malaise, Nausea
Clinical narrative: vaccine received at 0900 on 10 March 2023.  1600: symptoms began as body aches, malaise; took 800mg of OTC Ibuprofen @1630.  1900: symptoms increase to severe aches in all long bones, pelvis, and joints and perioral numbness and tingling.  2000: symptoms persisted, in addition to nausea and 104 temp, through the night into the morning of 11 March 2023; took acetaminophen at 2100.  11 March 2023: cycles of ibuprofen and acetaminophen reduced symptoms but did not relieve completely; symptoms persisted through the day with fever increasing at night. 12 March 2023: symptoms drastically reduced and able to relieve with 600mg OTC Ibuprofen at 0900 and 1600; right periocular swelling with pain and right testicle pain also experienced throughout the day.
Age: 36.0
Sex: M
Vaccine: DT
Symptoms: Pain, Paraesthesia, Periorbital swelling, Pyrexia, Testicular pain
Clinical narrative: vaccine received at 0900 on 10 March 2023.  1600: symptoms began as body aches, malaise; took 800mg of OTC Ibuprofen @1630.  1900: symptoms increase to severe aches in all long bones, pelvis, and joints and perioral numbness and tingling.  2000: symptoms persisted, in addition to nausea and 104 temp, through the night into the morning of 11 March 2023; took acetaminophen at 2100.  11 March 2023: cycles of ibuprofen and acetaminophen reduced symptoms but did not relieve completely; symptoms persisted through the day with fever increasing at night. 12 March 2023: symptoms drastically reduced and able to relieve with 600mg OTC Ibuprofen at 0900 and 1600; right periocular swelling with pain and right testicle pain also experienced throughout the day.
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; administered an expired dose of GARDASIL 9; This spontaneous report was received from a consumer referring to her son, a 11 year old male patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  In June 2023, the patient was administered an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. It was expired by 3 months (expired product administered). No additional adverse event (AE) was reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reports products that experienced temperature excursion over the weekend were administered to a patient. Products were administered 2/13/2023.       ?    Names of vaccines involved (including lot/exp) PEDVAX HIB W015926 2/14/2025; ROTATEQ 187; This spontaneous report was received from a registered nurse referring to a patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 13-FEB-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # 1879875, expiration date 19-NOV-2023; strength, dose were not reported)orally and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # W015926, expiration date 14-FEB-2025; strength, dose, route were not reported) for prophylaxis. The vaccines experienced temperature excursion above 9 degree Celsius (13.25 degree Celsius) for 2 hours 32 minutes and 0 seconds (product storage error). There was no previous temperature excursion. No adverse event was reported.
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator post expiry; No adverse event; The first dose administered on 04-Jan-2023 and second dose administered on 02-Mar-2023; It was inadvertently given a few days after expiring; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose administered on 04-Jan-2023 and second dose administered on 02-Mar-2023), EXPIRED PRODUCT ADMINISTERED (It was inadvertently given a few days after expiring), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator post expiry) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 060B22A and 052C22A) for COVID-19 prophylaxis.     The patient was not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 04-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2023 at 8:40 AM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose administered on 04-Jan-2023 and second dose administered on 02-Mar-2023) and EXPIRED PRODUCT ADMINISTERED (It was inadvertently given a few days after expiring). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator post expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose administered on 04-Jan-2023 and second dose administered on 02-Mar-2023), EXPIRED PRODUCT ADMINISTERED (It was inadvertently given a few days after expiring), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator post expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose administered on 04-Jan-2023 and second dose administered on 02-Mar-2023), EXPIRED PRODUCT ADMINISTERED (It was inadvertently given a few days after expiring) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator post expiry).    Concomitant medication was not provided.  Nurse reported that the vial was expired on 26-Feb-2023 and  the vial was initially stored in refrigerator on 21-Feb-2023. The vial did not undergo any temperature excursion. Treatment information was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported.; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 21-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot #W025273, expiration date: 10-AUG-2024, administered for prophylaxis (strength and route of administration were not provided) that was after a temperature excursion (product storage error). The vaccine was exposed to 34.7 degrees Fahrenheit for 13 hours 15 minutes 0 seconds. There was no previous excursion. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired dose of RECOMBIVAX was administered.  No other information provided.  No additional AEs or PQC reported. See related AEs 02342091, 02342106, 02342109, 02342114, 02342123.; This spontaneous report was received from Medical Assisstant and refers to a patient of an unspecified age, and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 05-DEC-2022, the patient was vaccinated with expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter, lot #U019135, expiration date: 22-NOV-2022, administered intramuscularly (IM) for prophylaxis (anatomical location, and strength were not provided) (expired vaccine used). No additional adverse events were provided. ; Sender's Comments:  US-009507513-2302USA008289:
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no other adverse event occurred. No other AE; patient received his first dose of MMRII and VARIVAX on 2/10/2023. The caller said the patient received his second dose of MMRII and VARIVAX on 3/3/2023; patient received his first dose of MMRII and VARIVAX on 2/10/2023. The caller said the patient received his second dose of MMRII and VARIVAX on 3/3/2023; This spontaneous report was received from a medical assistant, regarding a 4-year-old patient with unknown gender. The patient's concurrent conditions, concomitant medication, pertinent medical history and drug reactions/ allergies were not provided.   On 10-FEB-2023, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, anatomical location, lot number and expiration date were not provided) (product administered to patient of inappropriate age) and varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 03-MAR-2023, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot # w007180 has been verified to be a valid lot number, expiration date was reported as 01-MAR-2024, dose, route and anatomical location were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot # w022825 has been verified to be a valid lot number, expiration date was reported as 18-JUL-2024, dose, route and anatomical location were not provided) for prophylaxis (inappropriate schedule of product administration). No other adverse event occurred (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; Pharmacist reporting a dose of VAQTA with a labeled expiry 3/6/2023 was administered to a pediatric patient on 3/8/2023. Caller reports no temperature excursion involved. No additional information available. No additional AE/PQC reported; This spontaneous report was received from a pharmacist and refers to a pediatric patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 08-MAR-2023, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) at a dose of 0.5 milliliter, lot #W002894, expiration date 06-MAR-2023 (formulation defaulted as intramuscular injection, anatomical location, lot # and expiration date were not reported) for prophylaxis (expired product administered). No additional adverse events was reported (no adverse event).