chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: X-ray limb
Clinical narrative: Influenza, injectable, quadrivalent, preservative-free. I had a flu vaccine on Oct. 12th. I continued a rigorous workout routine through that weekend with no problems and a couple days into the next week without any issues. Then I started feeling some cold/flu symptoms and took a couple of days off from working out and that is when both my shoulders felt tight with limited mobility (as if I had just completed a lifting routine at the gym). A day after the tightness the pain started in my shoulders and continued radiating down to my hands over a period of about two weeks. My left shoulder and arm continue to experience moderate to severe pain starting in my shoulder and radiating down to my left hand. It feels as if my shoulder is popping in and out of alignment and impinging on the nerves. My right shoulder continues to have very mild pain (mostly in the morning) with occasional sharp pain spikes during normal movement throughout the day.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Myalgia, Pain in extremity
Clinical narrative: Right arm pain, redness, muscle aches, headache. 1/22 Ibuprofen, NORCO, BENADRYL. 1/23 and 24 ibuprofen.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Loss of consciousness, Nausea, Syncope, Urinary incontinence
Clinical narrative: Patient fainted in chair. Husband helped hold his wife in chair. Patient blacked out and when came back urinated on herself/floor. Then patient felt dizzy and put head on table. About 15 minutes later patient felt nausea and vomited. After vomiting patient felt better and left with husband and kids.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Patient fainted in chair. Husband helped hold his wife in chair. Patient blacked out and when came back urinated on herself/floor. Then patient felt dizzy and put head on table. About 15 minutes later patient felt nausea and vomited. After vomiting patient felt better and left with husband and kids.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Limb mass, Musculoskeletal pain
Clinical narrative: Very sore shoulder. Lump and bruising on inside of upper arm.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Fatigue, Pain in extremity
Clinical narrative: Patient stated that physically he was weak (laid on couch for 3 days), very fatiqued, pain in arm and down to elbow. Still had elbow pain a week later but it was getting better. Said 15 years ago he had similar reaction to flu shot (tired and fatigued).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pruritus, Skin tightness
Clinical narrative: Area was the size of my fist 3 by 3 inches red hot tight area on skin. I told patient to mark the margins and if got worse to make appointment with MD---that to take BENADRYL and put ice pack on her arm 15 minutes at a time to help with redness, itching. She felt physically sick and was leaving work because of it.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling of body temperature change, Headache, Insomnia, Pain
Clinical narrative: Severe headache, body aches, chills (got hot then cold). Also, could not sleep during these symptoms.
Age: 1.5
Sex: F
Vaccine: MMRV, PPV
Symptoms: Eye movement disorder, Febrile convulsion, Musculoskeletal stiffness, Pyrexia, Vomiting
Clinical narrative: After receiving the MMR, Varicella, and Pneumococcal vaccines all on the same day (1/11/19), patient ran a fever all day on 1/20/19. However, she was still active and showed no other symptoms. We treated her fever throughout the day by alternating between ibuprofen and TYLENOL. By 11:15pm, patient's temperature had reached 103, and she had a febrile seizure. Her body went stiff and her eyes rolled to the side. She stayed this way for several seconds before coming out of it, and then she vomited. 911 was called. Patient was taken to the ER that night and then seen by a doctor at her pediatrician's office the next day, and this doctor confirmed that all of this was a side effect of the MMR, which was not explained to us prior to the administration of the vaccine. Now that she has had this febrile seizure, patient is at increased risk for future seizures and epilepsy.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Flushing, Swelling face
Clinical narrative: Vaccine given at 2pm 01/13/19, at 6pm had facial flushing and swelling, resolved with benadryl. At 1am 01/14/1, woke with facial flushing and swelling again, this time with shortness of breath, went to ED.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, PNC13
Symptoms: Cardiac arrest, Central venous catheterisation, Coma scale abnormal, Cyanosis, Death
Clinical narrative: Patient found unresponsive at home. Brought to the emergency room by EMS. Found to be in asystole, cyanotic and GCS = 3. Cardiopulmonary resuscitation initiated and central line placed, but patient remained unresponsive. Patent was pronounced dead at 02:41.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, PNC13
Symptoms: Resuscitation, Unresponsive to stimuli
Clinical narrative: Patient found unresponsive at home. Brought to the emergency room by EMS. Found to be in asystole, cyanotic and GCS = 3. Cardiopulmonary resuscitation initiated and central line placed, but patient remained unresponsive. Patent was pronounced dead at 02:41.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: 12 hours after dose began shivering uncontrollably. 16 1/2 hrs later temperature was 100.9 orally. Began having muscle pain and pain in the right occipital area of side of head, 17 1/2 hrs later temperature was 101.5 orally. Symptoms continued unabated until 24 hrs after onset when they started to subside. By 36 hours, the symptoms were gone  All that remained was a sore arm.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain, Paraesthesia, Sleep disorder
Clinical narrative: 2 months of pain with pressure and certain common arm movements, sometimes with tingling or numbness. Can't sleep on that side secondary to pain. Referral made to P.T. for treatment. Pain started in 1 wk after injection, after normal post-vaccination soreness resolved. Pt didn't present to care for the problem until 2 months later w/persistent symptoms. First referred for treatment (P.T.) initiated at this visit. Focal point of pain is in deltoid, 3 cm below acromion. Pt. does have pain and impairment (likely secondary to pain) with focal musculoskeletal testing.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient states she had swelling and redness all through the upper deltoid region to her elbows. Also said her neck itched. Told her to call her MD. MD prescribed Prednisone and ZYRTEC.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: Developed a 10x6 cm round red area I (L) thigh. Treated with BENADRYL Dx fat necrosis.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse), on 12-Oct-2018, concerns a 39-year-old, adult female patient. On 10-Oct-2018, the pregnant patient was administered an expired suspect vaccine FLUCELVAX QIVc [batch number: 195215, expiry date: 30-Apr-2018, dose, route of administration and anatomical location: not reported]. At the time of this report, no adverse events were reported. This case was linked to case 201804438 due to the same reporter.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other healthcare professional on 08-Oct-2018, concerns a 45-year-old, adult, female patient. The patient had no medical history. The patient did not receive any concomitant medications. Since an unspecified date, FLUCELVAX QIVc vaccine underwent first temperature excursion, probably at 30.9 Fahrenheit (explicitly coded as incorrect product storage) for approximately 08 hours (reported as worst-case scenario was 8 hours). On 04-Oct-2018, the patient was administered FLUCELVAX QIVc vaccine [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252659 and expiry date: 31-May-2019] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse events were reported. The reporter assessed this case as non-serious. This case 201804346 was cross-linked to case 201804345 due to same reporter.
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Device leakage, No adverse event, Product closure issue, Wrong technique in product usage process
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 14-Nov-2018 (initial and follow-up processed together), concerns a male patient of unspecified age. It was reported that, whenever the flu vaccine was withdrawn, the vaccine leaked out from the rubber stopper. As the secured lock was popped off the vial the rubber stopper was dented in and off a little. It was reported that, when the nurses removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole where the medication leaked. The vials leaked and only 4 vials were leaking so far. On 05-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from a leaked vial. There were only 5 doses left out of the 10 doses in the vial. It was reported that sample vials were available in which they had one opened vial and 46 left. The package was not damaged, but the rubber stopper was damaged. From the withdrawal of first vaccine, the leakage was observed. The needle used was 25-gauge needle and the syringe were 3 ml syringe. The user had added air to the vial from the syringe. No adverse events were reported after administration of the vaccine. The reporter assessed the case as non-serious. This case 201804367 was cross-linked with the original case 201804366 due to the same reporter. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034101. Based on the QA investigation report, it was concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A known trend was identified for the FLUCELVAX batches from the 2018/2019 FLUCELVAX commercial season for vials leaking at the stopper during dosing. A review revealed that the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It is known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be user-improper handling. Follow up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in event tab. The narrative was amended accordingly.
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: No adverse event, Product administration error, Product closure issue, Product leakage, Wrong technique in product usage process
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 14-Nov-2018 (initial and follow-up processed together), concerns a male patient of unspecified age. It was reported that, whenever the flu vaccine was withdrawn, the vaccine leaked out from the rubber stopper. As the secured lock was popped off the vial the rubber stopper was dented in and off a little. It was reported that, when the nurses removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole where the medication leaked. The vials leaked and only 4 vials were leaking so far. On 05-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from a leaked vial. There were only 5 doses left out of the 10 doses in the vial. It was reported that sample vials were available in which they had one opened vial and 46 left. The package was not damaged, but the rubber stopper was damaged. From the withdrawal of first vaccine, the leakage was observed. The needle used was 25-gauge needle and the syringe were 3 ml syringe. The user had added air to the vial from the syringe. No adverse events were reported after administration of the vaccine. The reporter assessed the case as non-serious. This case 201804367 was cross-linked with the original case 201804366 due to the same reporter. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034101. Based on the QA investigation report, it was concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A known trend was identified for the FLUCELVAX batches from the 2018/2019 FLUCELVAX commercial season for vials leaking at the stopper during dosing. A review revealed that the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It is known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be user-improper handling. Follow up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in event tab. The narrative was amended accordingly.
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other healthcare professional on 08-Oct-2018, concerns a 46-year-old, adult, male patient. The patient had no medical history. The patient did not receive any concomitant medications. Since an unspecified date, FLUCELVAX QIVc vaccine underwent first temperature excursion, probably at 30.9 Fahrenheit for approximately 08 hours (reported as worst-care scenario was 8 hours). On 04-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252659 and expiry date: 31-May-2019] which underwent temperature excursion. At the time of this report, no adverse event was reported. The reporter assessed this case as non-serious. This case 201804345 was cross-linked to case 201804346 due to same reporter.
Age: 2.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 02-Oct-2018, concerns a 31-month-old, female child patient. The patient was healthy and had no medical history. The patient did not receive any concomitant medications. On 02-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252661, expiry date: 31-May-2019, route of administration and anatomical location: not reported). The patient did not experience any adverse event after the vaccination. The reporter assessed the case as non-serious.
Age: 57.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 57-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F, (explicitly coded as incorrect product storage). On 13-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experienced any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804100 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 68.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 25-Sep-2018, concerning a 68-year-old, elderly female patient. The patient's medical history and concomitant medications were not reported. On 24-Sep-2018, the vaccine was left in cooler and the temperature reached 34.4F, which was out of the recommended temperature range for 45 minutes and the average temperature was 35.4F. It was the first excursion. On 24-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number 252657 and expiry date: 31-May-2019) which underwent temperature excursion. The patient did not experience any adverse event after the vaccination. The reporter assessed the case as non-serious. This case 201804056 was cross-linked to source case 201804054 due to the same reporter. Follow-up report received from the reporter on 25-Oct-2018: The reporter confirmed the date of temperature excursion and vaccine administration (24-Sep-2018). The narrative was amended accordingly.
Age: 42.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 42-year-old, concerning a 42-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 13-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804103 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Vaccination error
Clinical narrative: This is a spontaneous case, initially received from other health professional on 08-Oct-2018, concerning a 35-year-old, adult, female patient. The patient had no medical history. The patient did not receive any concomitant medications. On 05-Oct-2018 (Friday), the doses were withdrawn from FLUCELVAX multi-dose vial (MDV). On 08-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252230 and expiry date: 31-May-2018), which was pre-drawn three days in advance. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804361 was cross-linked to case 201804360 due to the same reporter.
Age: 69.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 69-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 15-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804110 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up report received from reporter on 14-Nov-2018: The med info number (SEQ18-02667) was added in additional information tab. No new information was received. Hence, no changes were done in the narrative.
Age: 65.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerns a 65-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 15-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804109 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 17-Sep-2018, concerns a 12-year-old, male adolescent patient. The patient's medical history and concomitant medications were not reported. It was reported that, FLUCELVAX QIVc was out of temperature and exposed to temperature 55F for 1 hour and 45 minutes. On 15-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 252381, expiry date: 31-May-2019) which underwent temperature excursion. At the time of this report, no adverse effects were noted after the vaccination.
Age: 70.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerns a 70-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 14-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804108 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 65.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerns a 65-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 17-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804114 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: The med info number (SEQ18-02667) was added in the additional information tab. No new information was received. Hence, no changes were done in the narrative.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 18-Sep-2018, from other healthcare professional, concerns a 34-year-old, adult female patient. The patient had no medical history. The patient's concomitant medications included: calcium and fish oil for unknown indications. On 18-Sep-2018, the patient was administered expired FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195245 and expiry date: 20-Jun-2018). The patient was observed and revaccinated. At the time of this report, no adverse events were reported. The reporter assessed the case as non-serious. Non-significant follow up received from the reporter on 08-Oct-2018: The route of administration of the vaccine was confirmed as intramuscular. No new information was received.
Age: 80.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning an 80-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 13-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804102 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 26-Sep-2018, concerns a 21-year-old, adult female patient. The patient's concomitant medication included ZITHROMAX. On 24-Sep-2018, the vaccines were out of the recommended range for 1 hour and minimum temperature reached was 33.8 Fahrenheit. It was the first temperature excursion (explicitly coded as incorrect product storage). On the same day, the patient was administered FLUCELVAX (QIVc) that underwent temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252670 and expiry date: 30-Jun-2019] (explicitly coded as drug administration error). The patient did not experience adverse event after administration of the vaccine. The reporter assessed the case as non-serious. This case (201804151) is linked to case 201804150 reported by same reporter.
Age: 21.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional on 26-Sep-2018, concerns a 21-year-old, adult, male patient. The patient's concomitant medications included GARDASIL 9. On 24-Sep-2018, the vaccines were out of the recommended range for 1 hour and minimum temperature reached was 33.8 Fahrenheit. It was the first temperature excursion (explicitly coded as incorrect product storage). On the same day, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252670 and expiry date: 30-Jun-2019), that underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse event after administration of the vaccine. The reporter assessed the case as non-serious. This case was cross-linked to the case: 201804150 reported by the same reporter.
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 07-Oct-2018, concerning a 3-year-old, female child patient. On 07-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc [batch number: 252230, expiry date: 30-Jun-2019, dose, route of administration and anatomical location: not reported]. At the time of this report, no adverse event were reported after the vaccination. Follow-up report received on 30-Oct-2018: The expiry date of the suspect vaccine was changed from 30-Jun-2015 to 30-Jun-2019 in the product tab. Hence, the previously coded event 'expired vaccine used' was deleted from the event tab. The narrative and case comment were amended accordingly.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist) on 18-Sep-2018, concerns a 55-year-old, adult male patient. The patient received FLUCELVAX QIVc last year (historical drug) and had experienced a little pain. On 18-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252656 and expiry date: 31-May-2019). As soon as the pharmacist administered the vaccine, the patient suddenly developed swelling and some redness at the site of the injection (coded as immediate post-injection reaction). The pharmacist applied ice at the site of injection. It was reported that the events did not worsened, and the swelling went down a little bit. The patient was observed for 15 minutes while applying ice and was advised by the pharmacist to continue to use ice after leaving the pharmacy. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious. Follow-up received from the pharmacist on 15-Oct-2018: The pharmacist reported that the patient had recovered from the event, hence the outcome of the event (immediate post-injection reaction) was changed from not recovered to recovered in the event tab. It was also reported that the patient started recovering from the events on the same day of vaccination. Narrative was amended accordingly.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Dysstasia, Exposure during pregnancy, Fatigue, Grip strength decreased, Heart rate increased
Clinical narrative: This spontaneous case, initially received from other non-health professional on 08-Oct-2018, concerns a 29-year-old, adult pregnant patient. The patient had no historical condition. The patient had one previous pregnancy. There were no maternal and paternal medical history relevant to the pregnancy. The patient's concomitant medications included an unspecified thyroid medication and Prenatal vitamins for unspecified indications. On 01-Oct-2018, the patient (at 36 weeks of gestation period) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). On 02-Oct-2018 (reported as Tuesday), one day after vaccination, the patient woke up feeling stiff and by the evening, she needed help from her husband to stand up. The patient had slight fever and her heart rate was 130 (increased). On 05-Oct-2018 (reported as Friday), the patient could not get up without assistance and was still stiff and sore if she laid down or stood up. On 06-Oct-2018 (reported as Saturday), the patient was almost better, but her hands and forearms felt very weak and stiff and it was hard to grasp anything. On 07-Oct-2018 (reported as Sunday), the patient's forearm was still weak, and it was hard for her to grip the steering wheel and she was getting tired for a while. At the time of this report, the patient was recovering from pain upon movement, activities of daily living impaired and slight fever. The outcome of the events stiffness, decreased ability to grasp, impaired driving ability, hands weakness and tiredness were not reported. The patient's estimated date of delivery was 05-Nov-2015. The reporter assessed the case as non-serious.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Muscular weakness, Musculoskeletal stiffness, Pain
Clinical narrative: This spontaneous case, initially received from other non-health professional on 08-Oct-2018, concerns a 29-year-old, adult pregnant patient. The patient had no historical condition. The patient had one previous pregnancy. There were no maternal and paternal medical history relevant to the pregnancy. The patient's concomitant medications included an unspecified thyroid medication and Prenatal vitamins for unspecified indications. On 01-Oct-2018, the patient (at 36 weeks of gestation period) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). On 02-Oct-2018 (reported as Tuesday), one day after vaccination, the patient woke up feeling stiff and by the evening, she needed help from her husband to stand up. The patient had slight fever and her heart rate was 130 (increased). On 05-Oct-2018 (reported as Friday), the patient could not get up without assistance and was still stiff and sore if she laid down or stood up. On 06-Oct-2018 (reported as Saturday), the patient was almost better, but her hands and forearms felt very weak and stiff and it was hard to grasp anything. On 07-Oct-2018 (reported as Sunday), the patient's forearm was still weak, and it was hard for her to grip the steering wheel and she was getting tired for a while. At the time of this report, the patient was recovering from pain upon movement, activities of daily living impaired and slight fever. The outcome of the events stiffness, decreased ability to grasp, impaired driving ability, hands weakness and tiredness were not reported. The patient's estimated date of delivery was 05-Nov-2015. The reporter assessed the case as non-serious.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: This spontaneous case, initially received from other non-health professional on 08-Oct-2018, concerns a 29-year-old, adult pregnant patient. The patient had no historical condition. The patient had one previous pregnancy. There were no maternal and paternal medical history relevant to the pregnancy. The patient's concomitant medications included an unspecified thyroid medication and Prenatal vitamins for unspecified indications. On 01-Oct-2018, the patient (at 36 weeks of gestation period) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). On 02-Oct-2018 (reported as Tuesday), one day after vaccination, the patient woke up feeling stiff and by the evening, she needed help from her husband to stand up. The patient had slight fever and her heart rate was 130 (increased). On 05-Oct-2018 (reported as Friday), the patient could not get up without assistance and was still stiff and sore if she laid down or stood up. On 06-Oct-2018 (reported as Saturday), the patient was almost better, but her hands and forearms felt very weak and stiff and it was hard to grasp anything. On 07-Oct-2018 (reported as Sunday), the patient's forearm was still weak, and it was hard for her to grip the steering wheel and she was getting tired for a while. At the time of this report, the patient was recovering from pain upon movement, activities of daily living impaired and slight fever. The outcome of the events stiffness, decreased ability to grasp, impaired driving ability, hands weakness and tiredness were not reported. The patient's estimated date of delivery was 05-Nov-2015. The reporter assessed the case as non-serious.
Age: 15.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 15-year-old, adolescent patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 13-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804101 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Mod info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 69.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerns a 69-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 13-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804106 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 43.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 43-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 06-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804079 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 26-Sep-2018, concerns a 56-year-old, adult female patient. The patient's concomitant medications included SYNTHROID and AMBIEN. On 24-Sep-2018, the vaccines were out of the recommended range for 1 hour and minimum temperature reached was 33.8 Fahrenheit. It was the first-time temperature excursion occurred (explicitly coded as incorrect product storage). On the same day, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252670 and expiry date: 30-Jun-2019) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse events after administration of the vaccine. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect route of product administration, No adverse event, Underdose, Wrong product administered
Clinical narrative: This spontaneous case, initially received from other health professional on 27-Sep-2018, concerns a female patient of an unspecified age. On 27-Sep-2018, the patient was administered FLUCELVAX QIVc instead of tuberculosis (TB) vaccine [dose: 0.1 ml, route of administration: intradermal, anatomical location: arm, batch number: 252226, expiry date: 31-May-2019] (explicitly coded as vaccine under dose, inappropriate route of vaccination and wrong vaccine administered). No adverse events report after administration of the vaccine. The reporter assessed this case as non-serious. Update received on 02-Nov-2018: Non-significant case correction (27-Sep-2018): The sentence in the narrative was changed from 'considering the event vaccine under dose as incidental nature and the events wrong vaccine administered and inappropriate route of vaccination as an accidental nature of the events' to 'considering the accidental nature of the events'. Follow-up received from the reporter on 03-Nov-2018: The reporter confirmed that the dose (0.1 ml) and route of administration (intradermal) of the vaccine. The anatomical location (arm) was added. No new information was available regarding the patient's age and adverse events. The narrative was amended accordingly.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 55-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperature in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 08-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804080 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administration error
Clinical narrative: This is a spontaneous case, initially received from other health professional on 08-Oct-2018, concerning a 33-year-old, adult, female patient. The patient had no medical history. The patient did not receive any concomitant medications. On 05-Oct-2018 (Friday), the doses were withdrawn from FLUCELVAX Multi-dose vial (MDV). On 08-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252230 and expiry date: 31-May-2018), which was pre-drawn three days in advance (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804360 was cross-linked to case 201804361 due to the same reporter.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist) on 25-Sep-2018, concerns a 59-year-old, adult male patient. On 24-Sep-2018, the suspect vaccine, FLUCELVAX QIVc was left in the cooler and the temperature reached 34.4-degree F. The average of the incident was about 35.4-degree F for a period for 45 minutes. This was the first-time excursion. On 24-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252657 and expiry date: 31-May-2019) which underwent temperature excursion. The patient did not experience any adverse event after the vaccination. The reporter assessed the case as non-serious. This case was linked to case number: 201804054 (original case) due to same reporter. Follow-up report received from the reporter on 25-Oct-2018: The reporter confirmed that, the vaccine was administered on 24-Sep-2018 and temperature excursion also occurred on 24-Sep-2018. The narrative was amended accordingly.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist) on 25-Sep-2018, concerns a 53-year-old, adult female patient. On 24-Sep-2018, the suspect vaccine, FLUCELVAX QIVc was left in the cooler and the temperature reached 34.4-degree F. The average of the incident was about 35.4-degree F for a period for 45 minutes. This was the first-time excursion (coded as incorrect product storage). On 24-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252657 and expiry date: 31-May-2019) which underwent temperature excursion (coded as drug administration error). The patient did not experience any adverse event after the vaccination. The reporter assessed the case as non-serious. This case 220180458 was linked to case number: 201804054 due to same reporter. Follow-up report received from the reporter on 25-Oct-2018: The reporter confirmed the date of temperature excursion and vaccine administration (24-Sep-2018). The narrative was amended accordingly.