chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gastrointestinal wall thickening, Haematocrit increased, Haemoglobin normal, Hypertension, Hypotension
Clinical narrative: 84 year old female, presented to ED for abdominal pain, nausea vomiting and had eaten a ham sandwich prior to symptom onset.  In the ED she was normothermic and initially hypertensive. TRACS consulted in ER. CT abd/pelvis showing mild ileal wall thickening suggestive of enteritis, no obstruction or other acute abnormality. Overnight had worsening hypotension, required bipap support and rising lactate.  She had worsening pressor requirements  and diagnosed with visceral ischemia, vascular consulted. Trauma surgery, Pulmonary medicine and Vascular physicians deemed patient poor prognosis and high risk and patient taken to OR for an SMA embolectomy  ex-lap, returned to CVCU hemodynamically unstable and passed away.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Intestinal ischaemia, Lung opacity, Mesenteric arterial occlusion, Nausea, Osteoarthritis
Clinical narrative: 84 year old female, presented to ED for abdominal pain, nausea vomiting and had eaten a ham sandwich prior to symptom onset.  In the ED she was normothermic and initially hypertensive. TRACS consulted in ER. CT abd/pelvis showing mild ileal wall thickening suggestive of enteritis, no obstruction or other acute abnormality. Overnight had worsening hypotension, required bipap support and rising lactate.  She had worsening pressor requirements  and diagnosed with visceral ischemia, vascular consulted. Trauma surgery, Pulmonary medicine and Vascular physicians deemed patient poor prognosis and high risk and patient taken to OR for an SMA embolectomy  ex-lap, returned to CVCU hemodynamically unstable and passed away.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Platelet count normal, Pleural effusion, Positive airway pressure therapy, Pulmonary oedema, Pulmonary septal thickening
Clinical narrative: 84 year old female, presented to ED for abdominal pain, nausea vomiting and had eaten a ham sandwich prior to symptom onset.  In the ED she was normothermic and initially hypertensive. TRACS consulted in ER. CT abd/pelvis showing mild ileal wall thickening suggestive of enteritis, no obstruction or other acute abnormality. Overnight had worsening hypotension, required bipap support and rising lactate.  She had worsening pressor requirements  and diagnosed with visceral ischemia, vascular consulted. Trauma surgery, Pulmonary medicine and Vascular physicians deemed patient poor prognosis and high risk and patient taken to OR for an SMA embolectomy  ex-lap, returned to CVCU hemodynamically unstable and passed away.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Scan with contrast abnormal, Spinal osteoarthritis, Spondylolisthesis, Thromboembolectomy, Vomiting
Clinical narrative: 84 year old female, presented to ED for abdominal pain, nausea vomiting and had eaten a ham sandwich prior to symptom onset.  In the ED she was normothermic and initially hypertensive. TRACS consulted in ER. CT abd/pelvis showing mild ileal wall thickening suggestive of enteritis, no obstruction or other acute abnormality. Overnight had worsening hypotension, required bipap support and rising lactate.  She had worsening pressor requirements  and diagnosed with visceral ischemia, vascular consulted. Trauma surgery, Pulmonary medicine and Vascular physicians deemed patient poor prognosis and high risk and patient taken to OR for an SMA embolectomy  ex-lap, returned to CVCU hemodynamically unstable and passed away.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: White blood cell count increased
Clinical narrative: 84 year old female, presented to ED for abdominal pain, nausea vomiting and had eaten a ham sandwich prior to symptom onset.  In the ED she was normothermic and initially hypertensive. TRACS consulted in ER. CT abd/pelvis showing mild ileal wall thickening suggestive of enteritis, no obstruction or other acute abnormality. Overnight had worsening hypotension, required bipap support and rising lactate.  She had worsening pressor requirements  and diagnosed with visceral ischemia, vascular consulted. Trauma surgery, Pulmonary medicine and Vascular physicians deemed patient poor prognosis and high risk and patient taken to OR for an SMA embolectomy  ex-lap, returned to CVCU hemodynamically unstable and passed away.
Age: 76.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency
Age: 93.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen and should not have been
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: I did not have an adverse response to the vaccine. I tested positive for COVID 11/12/2022. I had sinus headache/cough/runny nose/sore throat/fever/muscle aches for 2 days. I had a video visit to have Paxlovid prescribed. I took it for 2 days, but I was getting better anyway, so I discontinued it. I had mild/moderate cough/runny nose/sore throat for 2 weeks. Now I'm back to my usual self.  I had a flu vaccine on the same day, but did not receive documentation of what type or lot number
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sinus headache
Clinical narrative: I did not have an adverse response to the vaccine. I tested positive for COVID 11/12/2022. I had sinus headache/cough/runny nose/sore throat/fever/muscle aches for 2 days. I had a video visit to have Paxlovid prescribed. I took it for 2 days, but I was getting better anyway, so I discontinued it. I had mild/moderate cough/runny nose/sore throat for 2 weeks. Now I'm back to my usual self.  I had a flu vaccine on the same day, but did not receive documentation of what type or lot number
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received a third dose of the Pfizer covid-19 monovalent vaccine instead of the bivalent vaccine indicated for the 3rd dose indicated in the most recent guidance by the CDC.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Salivary hypersecretion
Clinical narrative: Mouth watering,
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Blood test, Deep vein thrombosis, Electrocardiogram
Clinical narrative: Angina, DVT
Age: 82.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccinated.  Revax wanted
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. Dose administered. Offered revaccination
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Eye disorder, Hypoaesthesia, Laboratory test
Clinical narrative: lightning inside eye, hands numbness
Age: 94.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. Dose administered. Offered revaccination. Revax unwanted.
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient stated he did not have his vaccine record but was determined to be eligible based on the information he gave about his previous vaccinations. This was a incentive vaccination event and the patient just wanted gift cards. We found out he was given his bivalent booster a month earlier when we were at the same site.
Age: 91.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency
Age: 70.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Unevaluable event
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chronic spontaneous urticaria
Clinical narrative: Chronic spontaneous urticaria
Age: 81.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Pts states that his arm was very sore the day after receiving vaccine. He states that it has improved a lot but still sore 5 days post vaccination. There is no redness/swelling. This is not unusual but I am reporting because patient brought it to my attention. I answered YES to Item 20 because the patient is recovering.
Age: 90.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency
Age: 16.0
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms. will consider revax
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms. will consider revax
Age: 71.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms. will consider revax
Age: 85.0
Sex: M
Vaccine: FLU4
Symptoms: Apnoeic attack, Cardiac arrest, Cardiac telemetry abnormal, Death, Incorrect route of product administration
Clinical narrative: RN has erroneously given flu vaccine IV instead of IM. Patient's breathing slowed down-- > became apneic.  Telemetry applied -  flat line.  No spontaneous breathing.  No pulse or heart beat.  Pupils dilated.  Suspected PE. Time of death 10:35 am
Age: 85.0
Sex: M
Vaccine: FLU4
Symptoms: Mydriasis, Pulse absent, Respiratory arrest, Respiratory rate decreased
Clinical narrative: RN has erroneously given flu vaccine IV instead of IM. Patient's breathing slowed down-- > became apneic.  Telemetry applied -  flat line.  No spontaneous breathing.  No pulse or heart beat.  Pupils dilated.  Suspected PE. Time of death 10:35 am
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms. will consider revax
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: patient was inadvertently given the 5-11 dose of the covid Pfizer bivalent booster. no pain, redness, or symptoms experienced. family was contacted immediately. she was then given a 2nd dose within 30 min of the 5-11 dose of the bivalent booster to complete the full age appropriate dose.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, COVID-19, Erythema, Pruritus, SARS-CoV-2 test positive
Clinical narrative: Mild whole body red spots, itching beginning several days after initial injection. More severe whole body spots, itching following 2nd Vaccine injection 03/05/2021 followed up by severe leg and pubic hair loss over following months, continued skin/itching/hair loss following 3rd (booster) injection 12/14/2021. Came down with positive Covid infection July 08, 2022 and in subsequent months up until present periodic severe itching at various body locations and almost total loss of scalp hair, and whole-body joint pain and episode of Vertigo.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Mild whole body red spots, itching beginning several days after initial injection. More severe whole body spots, itching following 2nd Vaccine injection 03/05/2021 followed up by severe leg and pubic hair loss over following months, continued skin/itching/hair loss following 3rd (booster) injection 12/14/2021. Came down with positive Covid infection July 08, 2022 and in subsequent months up until present periodic severe itching at various body locations and almost total loss of scalp hair, and whole-body joint pain and episode of Vertigo.
Age: 87.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Oxygen saturation, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms. will consider revax
Age: 76.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency
Age: 71.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms. will consider revax
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms. will consider revax
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: SORE ARM SET IN AFTER VACCINE, HAS STAYED FOR 2 MONTHS BUT NOW ONLY HURTS WHEN MOVING ARM CERTAIN WAY
Age: 45.0
Sex: U
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 9.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Clinic was serving patients and their was a gift card incentive. Patient was screened and he stated that he was eligible based on the last date of his covid vaccination. After patient received vaccine, found out patient received a bivalent booster on 11/1.
Age: 52.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Induration, Injection site reaction, Injection site warmth, Joint range of motion decreased, Pain in extremity
Clinical narrative: On 12/14/2022 at 2pm, patient noticed three red blotches on left arm below deltoid that was warm to the touch.  Her arm was hurting and was unable to lift past shoulder height.  On the evening of 12/15/2022, patient came to pharmacy and rash was tender and about a 5 inch circle with a hard knot in the middle.  Patient went to medical clinic and was prescribed antibiotics.
Age: 52.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Rash, Rash macular, Tenderness
Clinical narrative: On 12/14/2022 at 2pm, patient noticed three red blotches on left arm below deltoid that was warm to the touch.  Her arm was hurting and was unable to lift past shoulder height.  On the evening of 12/15/2022, patient came to pharmacy and rash was tender and about a 5 inch circle with a hard knot in the middle.  Patient went to medical clinic and was prescribed antibiotics.
Age: 43.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: The patient is complaining of constant arm pain since the day of the immunization to the point where she is unable to raise it above her head. The adverse effects were reported 5 days after the immunizations were given and the patient stated the pain has not improved. There was no itching, redness or other physical symptom reported.  The rph counseled on around the clock use of ibuprofen for 48 hours at which point she will check on the patient again via a phone call.  The rph called the patient and left a message asking for a call back with an update. At the time this is written, pt has not called back yet.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Atrial fibrillation, Bronchoalveolar lavage abnormal, Bronchoscopy abnormal
Clinical narrative: He had just been recovering from his second bout of COVID requiring hospitalization in October 2022.  (First COVID + was January 2022 following Moderna booster shot in August 2021, with initial moderna series Jan/Feb 2021.)  At his outpatient follow up after discharge from COVID hospitalization, someone decided to give him the moderna bivalent booster.  A week later, he was readmitted with SOB and hypoxemia and diagnosed with pulmonary emboli by CTA on 11/15/22.  He was heparinized.  CT showed worsening ground glass infiltrates.  He underwent bronchoscopy with BAL and TBNA which showed lymphocytic inflammation with all other Cx and infectious work up negative.  He was discharged and returned to hospital with worsening dyspnea and hypoxemia and now + for H1N1 influenza A with worsening hypoxemic respiratory failure that continues to progress despite steroids.  He did receive his Fluad influenza vaccination on September 1st 2022 with lot #346341.  He now has developed A fib with RVR and has a small pericardial effusion and intermittently mildly elevated troponin.  He is at high risk of death from this constellation of events.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram thorax abnormal, Culture negative, Dyspnoea, Endobronchial ultrasound transbronchial needle aspiration, Hypoxia
Clinical narrative: He had just been recovering from his second bout of COVID requiring hospitalization in October 2022.  (First COVID + was January 2022 following Moderna booster shot in August 2021, with initial moderna series Jan/Feb 2021.)  At his outpatient follow up after discharge from COVID hospitalization, someone decided to give him the moderna bivalent booster.  A week later, he was readmitted with SOB and hypoxemia and diagnosed with pulmonary emboli by CTA on 11/15/22.  He was heparinized.  CT showed worsening ground glass infiltrates.  He underwent bronchoscopy with BAL and TBNA which showed lymphocytic inflammation with all other Cx and infectious work up negative.  He was discharged and returned to hospital with worsening dyspnea and hypoxemia and now + for H1N1 influenza A with worsening hypoxemic respiratory failure that continues to progress despite steroids.  He did receive his Fluad influenza vaccination on September 1st 2022 with lot #346341.  He now has developed A fib with RVR and has a small pericardial effusion and intermittently mildly elevated troponin.  He is at high risk of death from this constellation of events.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Influenza A virus test positive, Laboratory test normal, Lung infiltration, Lung opacity, Lymphocytosis
Clinical narrative: He had just been recovering from his second bout of COVID requiring hospitalization in October 2022.  (First COVID + was January 2022 following Moderna booster shot in August 2021, with initial moderna series Jan/Feb 2021.)  At his outpatient follow up after discharge from COVID hospitalization, someone decided to give him the moderna bivalent booster.  A week later, he was readmitted with SOB and hypoxemia and diagnosed with pulmonary emboli by CTA on 11/15/22.  He was heparinized.  CT showed worsening ground glass infiltrates.  He underwent bronchoscopy with BAL and TBNA which showed lymphocytic inflammation with all other Cx and infectious work up negative.  He was discharged and returned to hospital with worsening dyspnea and hypoxemia and now + for H1N1 influenza A with worsening hypoxemic respiratory failure that continues to progress despite steroids.  He did receive his Fluad influenza vaccination on September 1st 2022 with lot #346341.  He now has developed A fib with RVR and has a small pericardial effusion and intermittently mildly elevated troponin.  He is at high risk of death from this constellation of events.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pericardial effusion, Pulmonary embolism, Respiratory failure, Troponin increased
Clinical narrative: He had just been recovering from his second bout of COVID requiring hospitalization in October 2022.  (First COVID + was January 2022 following Moderna booster shot in August 2021, with initial moderna series Jan/Feb 2021.)  At his outpatient follow up after discharge from COVID hospitalization, someone decided to give him the moderna bivalent booster.  A week later, he was readmitted with SOB and hypoxemia and diagnosed with pulmonary emboli by CTA on 11/15/22.  He was heparinized.  CT showed worsening ground glass infiltrates.  He underwent bronchoscopy with BAL and TBNA which showed lymphocytic inflammation with all other Cx and infectious work up negative.  He was discharged and returned to hospital with worsening dyspnea and hypoxemia and now + for H1N1 influenza A with worsening hypoxemic respiratory failure that continues to progress despite steroids.  He did receive his Fluad influenza vaccination on September 1st 2022 with lot #346341.  He now has developed A fib with RVR and has a small pericardial effusion and intermittently mildly elevated troponin.  He is at high risk of death from this constellation of events.
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient stated he did not have his vaccination record, but when screened, answered questions that would make him eligible for booster. After vaccine was administered, found out patient had already received the bivalent booster on November 1st. This was a gift card incentive event. Patient wanted gift cards
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Pain, Sleep disorder
Clinical narrative: Pain, pressure, discomfort in left chest heart area. If sleeping on left side, pain will wake me up.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Alopecia areata, Alopecia universalis
Clinical narrative: Alopecia Areata started in April 2021, short remission, then severe relapse moving into alopecia universalis
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 10.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Incorrect product formulation administered, Pain in extremity
Clinical narrative: The patient received the monovalent 6-11 Moderna 0.5ml dose instead of the updated Moderna booster 6-11 dose. Patient had headache and a sore arm from vaccination per mother.
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac stress test, Electrocardiogram abnormal
Clinical narrative: Abnormal EKG. Further testing  required.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 11.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: Moderna monovalent 6-11 0.5ml given instead of bivalent booster dose
Age: 11.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: GAVE BIVALENT AS FIRST DOSE IN SERIES
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Condition aggravated, Diarrhoea, Facial pain, Head discomfort
Clinical narrative: Severe inflammation, colon inflammation with severe diarrhea for months, head pain and pressure, severe facial and neck pain, vertigo, long Covid worsened
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inflammation, Neck pain, Post-acute COVID-19 syndrome, Vertigo
Clinical narrative: Severe inflammation, colon inflammation with severe diarrhea for months, head pain and pressure, severe facial and neck pain, vertigo, long Covid worsened
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Spontaneous urticaria approximately 1 week post vaccination. Ongoing, responds to Diphenhydramine. No specific location on body: it?s completely random as to where the urticaria pops up. Dermatographia (head to toe) and pruritis on palms of hands is also present.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Bedridden, Burning sensation, Diarrhoea
Clinical narrative: Severe inflammation everywhere.  Bed ridden for weeks.  Muscle rigidity, muscle, bone and joint pain, severe sinus inflammation in face, severe neck pain (left especially) burning in arms, hands, feet and legs, severe pain, stomach upset, diarrhea, long Covid symptoms worsened.  Still in severe pain after 6 weeks!!
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Laboratory test, Malaise, Muscle rigidity, Myalgia
Clinical narrative: Severe inflammation everywhere.  Bed ridden for weeks.  Muscle rigidity, muscle, bone and joint pain, severe sinus inflammation in face, severe neck pain (left especially) burning in arms, hands, feet and legs, severe pain, stomach upset, diarrhea, long Covid symptoms worsened.  Still in severe pain after 6 weeks!!
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, White blood cell count increased
Clinical narrative: Severe inflammation everywhere.  Bed ridden for weeks.  Muscle rigidity, muscle, bone and joint pain, severe sinus inflammation in face, severe neck pain (left especially) burning in arms, hands, feet and legs, severe pain, stomach upset, diarrhea, long Covid symptoms worsened.  Still in severe pain after 6 weeks!!
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Laboratory test normal, Menstrual disorder, Oligomenorrhoea, Polymenorrhoea
Clinical narrative: Two weeks after her second Covid dose, patient is  on a permanent menstrual cycle, with 3-4 days break in between.  She has had all her labs and everything checks out fine. She was seen by a GYN and she suggested birth control to stop the bleeding, but even  that does not stop it. For the record, her period started at 12, and for the past 2 years , she has been on a regular cycle.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Periorbital swelling, Pruritus, Rash, Wheezing
Clinical narrative: Itching, rash, facial redness and swelling around eyes and audible wheezing within 15 minutes after vaccine was given
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event, Product administration error
Clinical narrative: Patient received Moderna COVID vaccine on 9/6/21 (lot # 034C21A), but received Pfizer COVID vaccine on 11/22/22 (lot # FP7140) as dose #2. This is an administration error, no adverse reaction occurred.
Age: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Food allergy, Headache, Loss of personal independence in daily activities, Malaise, Nausea
Clinical narrative: - Tylenol  -Advil I was sick after 1st 2 vaccine but developed Extremely bad headache after booster shot coupled with nausea.  It get bad sometime that I do not feel productive at all.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Intensive care, Intra-abdominal haemorrhage, Laboratory test
Clinical narrative: Patient was admitted toER on 11/12/22 at high elevation.  Patient blood oxygen was under 70%.  Patient was admitted to hospital and taken off of Plaxlovid and started on Remdesiver 5 day treatment.  Patient was recovering but on 12/17/22 complained of distended abdominal pain and was bleeding in her abdomen.  Emergency surgery was performed to stop the bleeding.  Patient was in ICU for 5 days then moved to a floor bed.  Discharged 1 day later to return home.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Surgery
Clinical narrative: Patient was admitted toER on 11/12/22 at high elevation.  Patient blood oxygen was under 70%.  Patient was admitted to hospital and taken off of Plaxlovid and started on Remdesiver 5 day treatment.  Patient was recovering but on 12/17/22 complained of distended abdominal pain and was bleeding in her abdomen.  Emergency surgery was performed to stop the bleeding.  Patient was in ICU for 5 days then moved to a floor bed.  Discharged 1 day later to return home.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: MA administered the Pfizer COVID-19 Vac Bivalent 16 hours after the vial was punctured. Vial was stored appropriately and was never out of temperature range.  No issues reported from patient at this time.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Flushing, Nausea
Clinical narrative: Narrative:  51yo female presented to PCP for pro-op clearance (total right knee replacement). During the visit, pt received a single 0.5mL dose of the influenza vaccine (Afluria). Pt experienced dizziness, flushing, and nausea within 5 minutes of vaccine administration. No treatment given. PCP monitored the pt for an additional 20 minutes before discharging patient in stable condition.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash & UrticariaPruritus Narrative:  I had mild rash and pruritus this tome that again started about around a week to 10 days after my shot. It is located in my armpits, ankle and lower abdomen/inguinal region. I believe it is mild at least in part because I've been on the other two meds this time of montelukast and loratidine. At this time, I plan to continue COVID boosters unless advised otherwise.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.).    No concomitant medicine were reported. No treatment medicine were reported. This case is for patient 2.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.; administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.), PRODUCT STORAGE ERROR (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.), PRODUCT STORAGE ERROR (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.), PRODUCT STORAGE ERROR (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.) and PRODUCT STORAGE ERROR (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.).    No relevant concomitant medications were reported. It was reported that 5 adult patients received expired Bivalent booster on 29 Nov 2022 (1 DOSE), 01 Dec 2022 (3 DOSES), 05 Dec 2022 (1 DOSE). Date the vial was initially stored in the refrigerator was 24 Oct 2022. No treatment medication reported.   This case was for the third patient of 5 patients.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.) and NO ADVERSE EVENT (No Adverse event) had not resolved. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.).    It was reported as five adult patients received expired Bivalent booster on 29nov2022 (1 dose), 01dec2022 (3 doses), 05dec2022 (1 Dose). The vial size was 2.5 ml  The vial was initially stored in the refrigerator on  24 Oct 2022  This case was for the fourth patient of 5 patients. The vial does not undergo any temperature excursions.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE's and no PQC's were reported; An expired dose of VARIVAX was administered today; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported.   On an 09-DEC-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, use as directed to prevent varicella infection (lot #T002843 with an expiration date on 23-JAN-2022) (strength, dose, and route of administration were not provided) (expired product administered) which was reconstituted with sterile diluent (MERCK STERILE DILUENT) (manufacturer unknown).   No additional adverse events were reported.
Age: 40.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Bell's palsy, Exposure during pregnancy, Facial paralysis
Clinical narrative: Gestation period when reaction/event was observed in the fetus ; 28; Went to ER, diagnosed with bell's palsy on left side.; Facial paralysis on left side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Dec2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: Apr2022. The patient was 28 weeks pregnant at the event onset. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 03Nov2022 as dose 1, single. Vaccination history included: BNT162b2 (Dose 3, dose Administration time- 18:15, Vaccine location=Right arm), administration date: 07Dec2021, when the patient was 39-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number-EW0153, dose Administration time=14:30, Prev dose Vaccine location=Right arm), administration date: 06May2021, when the patient was 39-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Prev dose Lot number- ER8732, dose Administration time-10:45,Vaccine location-Right arm), administration date: 08Apr2021, when the patient was 39-year-old, for COVID-19 immunization. The following information was reported: FACIAL PARALYSIS (medically significant) with onset 06Dec2022 at 12:30, outcome "not recovered", described as "Facial paralysis on left side"; BELL'S PALSY (medically significant) with onset 06Dec2022 at 12:30, outcome "not recovered", described as "Went to ER, diagnosed with bell's palsy on left side"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Gestation period when reaction/event was observed in the fetus ; 28". The events "went to er, diagnosed with bell's palsy on left side." and "facial paralysis on left side" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of bell's palsy, facial paralysis.  Clinical course: Patient received prednisone treatment. No covid was reported prior vaccination and post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Bell's palsy, Facial paralysis, Maternal exposure during pregnancy
Clinical narrative: Gestation period when reaction/event was observed in the fetus ; 28; Went to ER, diagnosed with bell's palsy on left side.; Facial paralysis on left side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Dec2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: Apr2022. The patient was 28 weeks pregnant at the event onset. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 03Nov2022 as dose 1, single. Vaccination history included: BNT162b2 (Dose 3, dose Administration time- 18:15, Vaccine location=Right arm), administration date: 07Dec2021, when the patient was 39-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number-EW0153, dose Administration time=14:30, Prev dose Vaccine location=Right arm), administration date: 06May2021, when the patient was 39-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Prev dose Lot number- ER8732, dose Administration time-10:45,Vaccine location-Right arm), administration date: 08Apr2021, when the patient was 39-year-old, for COVID-19 immunization. The following information was reported: FACIAL PARALYSIS (medically significant) with onset 06Dec2022 at 12:30, outcome "not recovered", described as "Facial paralysis on left side"; BELL'S PALSY (medically significant) with onset 06Dec2022 at 12:30, outcome "not recovered", described as "Went to ER, diagnosed with bell's palsy on left side"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Gestation period when reaction/event was observed in the fetus ; 28". The events "went to er, diagnosed with bell's palsy on left side." and "facial paralysis on left side" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of bell's palsy, facial paralysis.  Clinical course: Patient received prednisone treatment. No covid was reported prior vaccination and post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.