chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified patients. There was no information regarding the patient's medical history, concomitant medications drug reactions and allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, (lot# N015475, expiration date 18-MAY-2019; lot# N020686, expiration date 27-JUL-2019) for prophylaxis. Other improperly stored vaccines involved included RECOMBIVAX HB (lot# M035487, expiration date 23-FEB-2019; lot# M044032, expiration date 03-JUL-2019), VAQTA (lot# M039202, expiration date 30-JUN-2018; lot# N008823, expiration date 26-MAY-2018), GARDASIL 9 (lot# M040412, expiration date 30-JUN-2019; lot# N010497, expiration date 15-JAN-2020), PNEUMOVAX 23 (lot# M042324, expiration date 10-JUN-2018) and ROTATEQ (lot# M040269, expiration date 28-APR-2018; lot# M041184, expiration date 31-MAY-2018). Sterile diluent used for VARIVAX reconstitution was stored properly. Doses of VARIVAX was exposed to -14 Celsius degree to-10 Celsius degree for 48 hours. Doses of GARDASIL 9, ROTATEQ,  PNEUMOVAX 23, RECOMBIVAX HB, and VAQTA were exposed to temperature below 0 Celsius degree for 1 hour, 0 Celsius degree to 1 Celsius degree for 2.5 hours, and 9 Celsius degree to 25 Celsius degree for 82 hours. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. Follow-up information has been received from the physician on 23-JAN-2018 referring to the male patient. The physician stated her freezer vaccines were not an issue and were found to be "ok to use" after a discussion with agency and the vaccine stability data. Specific lot numbers or dates of vaccination were not available at this moment. He was vaccinated with improperly stored doses of GARDASIL 9. The following initials are patients who received vaccines that were stored in refrigerator and these patients are being contacted to be re-vaccinated. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1801USA004018:
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified patients. There was no information regarding the patient's medical history, concomitant medications drug reactions and allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, (lot# N015475, expiration date 18-MAY-2019; lot# N020686, expiration date 27-JUL-2019) for prophylaxis. Other improperly stored vaccines involved included RECOMBIVAX HB (lot# M035487, expiration date 23-FEB-2019; lot# M044032, expiration date 03-JUL-2019), VAQTA (lot# M039202, expiration date 30-JUN-2018; lot# N008823, expiration date 26-MAY-2018), GARDASIL 9 (lot# M040412, expiration date 30-JUN-2019; lot# N010497, expiration date 15-JAN-2020), PNEUMOVAX 23(lot# M042324, expiration date 10-JUN-2018) and ROTATEQ (lot# M040269, expiration date 28-APR-2018; lot# M041184, expiration date 31-MAY-2018). Sterile diluent used for VARIVAX reconstitution was stored properly. Doses of VARIVAX was exposed to -14 Celsius degree to-10 Celsius degree for 48 hours. Doses of GARDASIL 9, ROTATEQ, PNEUMOVAX 23, RECOMBIVAX HB, and VAQTA were exposed to temperature below 0 Celsius degree for 1 hour, 0 Celsius degree to 1 Celsius degree for 2.5 hours, and 9 Celsius degree to 25 Celsius degree for 82 hours. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. Follow-up information has been received from the physician on 23-JAN-2018 referring to the female patient. The physician stated her freezer vaccines were not an issue and were found to be "ok to use" after a discussion with MNSC and the vaccine stability data. Specific lot numbers or dates of vaccination were not available at this moment. She was vaccinated with improperly stored doses of VAQTA. The following initials are patients who received vaccines that were stored in refrigerator and these patients are being contacted to be re-vaccinated. Sender's Comments: US-009507513-1801USA004018.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Vomiting 3 times, nausea, pain in both arms.
Age: 0.58
Sex: M
Vaccine: DTAPIPV, HEP, PNC13
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: 7 month Well child appointment. The patient was given KINRIX with DTaP and IPV; instead of PEDIARIX. It is recommended for children between 4 and 6 yrs. of age. They also received Hepatitis B vaccine and a PCV13 the same day of the event.
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous case, was initially received on 27-Oct-2017 from a pharmacist, concerns a 03-year-old female child patient. The patient's medical history and concomitant medications were not reported. On 27-Oct-2017, the patient was administered with FLUCELVAX (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195238, expiry date: 31-May-2018). It was reported that, 3.5-year-old patient was administered with the vaccine (explicitly coded as inappropriate age at vaccine administration) and was observed for 30 minutes. No adverse reactions had occurred. The reporter assessed the report as non-serious. Significant case correction received with IRD 27-OCT-2017: The event "no adverse event" was deleted and expiry date of the product (31-May-2017) was corrected and narrative amended accordingly.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Mobility decreased
Clinical narrative: This initial spontaneous case, was received on 27-Oct-2017, from a nurse, concerning a 62-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 28-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number, expiry date: not reported). On an unspecified date in Aug-2017 (reported as 2 days post-vaccination), the patient had bursitis and difficulty in raising arm. The patient had not taken any treatment. At the time of the report, the patient had not recovered from the events. The reporter assessed the events as non-serious.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Haemorrhage, Injection site bruising, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 27-Oct-2017, concerning a 56-year-old adult female patient. The patient's medical history included osteoarthritis (unspecified date). The patient's concomitant medications include glucosamine and ibuprofen for an unknown indication. On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195237, expiry date: May-2018. On the same day, the patient had a pain, which described as stinging throbbing began during administration of the vaccine, little bleeding after the injection, which stopped in 2 minutes, quarter size welt hard spot started at the injection site. The welt resolved within 24-hours. The patient also had a bruise at the injection site, which resolved after 2 weeks. The same day (09-Oct-02017). The patient also developed injection site lump. No treatment medication was taken for the events. At the time of this report, the patient recovered from all the events. The reporter assessed the events as non-serious. Follow-up received on 22-Nov-2017: Added new event injection site lump. The outcome of the event slight pain was changed from not recovered to recovered. The event bruising was changed to injection site bruising. The narrative was amended accordingly. Non-significant follow up received on 04-Dec-2017: The reporter confirmed the start date of the event injection site lump as 09-Oct-2017.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site urticaria, Pain
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 27-Oct-2017, concerning a 56-year-old adult female patient. The patient's medical history included osteoarthritis (unspecified date). The patient's concomitant medications include glucosamine and ibuprofen for an unknown indication. On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195237, expiry date: May-2018. On the same day, the patient had a pain, which described as stinging throbbing began during administration of the vaccine, little bleeding after the injection, which stopped in 2 minutes, quarter size welt hard spot started at the injection site. The welt resolved within 24-hours. The patient also had a bruise at the injection site, which resolved after 2 weeks. The same day (09-Oct-02017). The patient also developed injection site lump. No treatment medication was taken for the events. At the time of this report, the patient recovered from all the events. The reporter assessed the events as non-serious. Follow-up received on 22-Nov-2017: Added new event injection site lump. The outcome of the event slight pain was changed from not recovered to recovered. The event bruising was changed to injection site bruising. The narrative was amended accordingly. Non-significant follow up received on 04-Dec-2017: The reporter confirmed the start date of the event injection site lump as 09-Oct-2017.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Accidental exposure to product, Exposure via skin contact, Underdose
Clinical narrative: This initial spontaneous case, received on 27-Oct-2017 was reported by other health professional and concerns a 33-year-old, adult, female patient. The patient's concomitant medications included: Vitamins (as reported) and potassium for an unknown indication. On 02-Oct-2017, the patient was administered with FLUCELVAX QIV (batch number: 195128, dose: less than a full dose (as reported), route of administration, anatomical location, expiry date: not reported). On the same day, while pulling the needle out, vaccine sprayed on the patient's face, hitting her glasses. It was reported that, while removing vial from carton, the vial or carton didn't appear to be wet. There was no product residue and no discoloration. It was reported that, leakage was between stopper and metal crimp and from needle insertion site at the stopper, no leaking was noted upon removing, the flip cap and metal crimp was appeared properly. Reporter stated that, there were no evidences of cracks or breakage on the vial. It was reported that, vaccine was drawn when the vial was noted to be leaked and the vaccine came out forcefully, hitting face and glasses as well. It was reported that, 25-gauge needle and 3 ml needle was used for vaccination. Reporter stated that, 3 or 4 times the vial had been pierced before leakage. No air was injected into the vial. It was reported that, while withdrawing doses, there was no overage drawn into syringe for aspiration. It was reported that, full dose was administered to the patient and there was no evidence of damage. This case was associated with PTC number (1025609). Based on the investigation performed, it was concluded that FLUCELVAX Batch 195128 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, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. The reporter assessed this case as non-serious. Non-significant follow-up received 15-Nov-2017: PTC number (1025609) was updated. Amended narrative accordingly. Follow-up received on 12-Dec-2017: PTC report was received. The narrative was amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Back pain, Dyspepsia, Exposure during pregnancy, Flatulence
Clinical narrative: This initial non-serious spontaneous case, received on 26-Oct-2017, reported by other non-health professional and concerns a female pregnant patient of unspecified age. On an unspecified date, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, expiry date and batch number: not reported) (explicitly coded as vaccine exposure during pregnancy). On the same day after administration of vaccine, the patient stated that she started having gas and experienced indigestion. It was reported that, gas travelled through her back and stomach which caused a lot of pain. At the time of this report, the outcome of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This initial non serious spontaneous case, was received from other health professional (nurse) on 24-Oct-2017, concerning a 53-year-old adult female patient. On 24-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195129, expiry date: 30-Apr-2018, route of administration: intramuscular, anatomical location: left deltoid). The reporter stated that while administration part of vaccine leaked out above the needle of the syringe. As a consequence, employee did not receive the full dose (explicitly coded as underdose) No adverse reaction was experienced after administration. The reported provided the outcome of the events was recovered as no adverse reaction reported.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial spontaneous case, received on 24-Oct-2017, reported by other non-health professional and concerns a 3-year-old male child. The patient had no medical history and concomitant medications received. On 23-Oct-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, batch number: 195236, expiry date: 31-May-2018, route of administration: intramuscular). It was reported that, the patient has not experienced any problems. Outcome of the events was not reported. The reporter considered this case as non-serious.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Mobility decreased, Muscle electrostimulation therapy, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: A day or two after the vaccine was administered I had flu symptoms and it was difficult to raise my right arm. I was given TAMIFLU at an urgent care clinic and my symptoms got better, but I was still unable to move my right shoulder. Today, almost 2.5 years later I am still unable to move my right arm. I believe the flu shot caused an RA flare that attacked and severely damaged my right shoulder joint and the nerves in that area making it paralyzed.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chest discomfort, Chest pain, Eye swelling, Hypoaesthesia
Clinical narrative: Pt experienced numbness in left leg, chest pain and tightness in chest as well as swollen eyes.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injection site pain, X-ray limb normal
Clinical narrative: Pt states that she received the flu shot on 9-28-17. Two weeks later she experienced pain in her left shoulder. She had an Xray and no abnormalities noted. She went back to the Dr. 2 weeks after that with continued discomfort and had a cortisone injection.
Age: 67.0
Sex: M
Vaccine: FLUC4
Symptoms: Diarrhoea
Clinical narrative: This non-serious initial spontaneous case, was received from Other Non-Health Professional on 24-Oct-2017, concerning a 67-year-old elderly patient of unspecified gender. On 20-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: Intramuscular, anatomical location: left deltoid, batch number: 195218, expiry date: 30-Apr-2018). On 21-OCT-2017, after 1 day of vaccination, the patient experienced diarrhea. The subject was treated with PEPTO-BISMOL for the event. At the time of this report, the outcome of event was not recovered (reported as symptoms are ongoing). The reporter assessed the event as non-serious. Significant case correction received 24-OCT-2017: The listedness of the event Diarrhoea (changed from unlisted to listed) was corrected.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure via skin contact, Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous case, was initially received on 23-Oct-2017, from other-health professional (nurse), concerning a 61-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 23-Oct-2017, the patient was administered with FLUCELVAX Quadrivalent (dose: less than 0.5 ml (as reported), batch number: 195229, expiry date: May-2018, route of administration, anatomical location: not reported). It was reported that, the patient was administered with the vaccine (25 gauge needle) and it leaked (explicitly considered as product leakage) down the patient's arm (explicitly considered as exposure via skin contact), hence the patient received only a partial dose (explicitly considered as incomplete dose administered). It was reported that leak was coming from the base of the needle and there were no signs of damage and before vaccination needle appeared tightly attached. The patient had no averse event and no treatment measures were given to the patient. This case was associated with PTC reference number: 1025634. Based on he investigation performed, it was concluded that FLUCELVAX (Batch number: 195229) was manufacturer in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process or related to the syringes or stopper components, and no trends were identified for the batch for leaking syringes. There was no internal root cause that could be confirmed and no external/user root cause could be determined. The reporter considered the events as non-serious. Follow-up received on 13-Nov-2017: Added new events exposure via skin contact and no adverse event. It was reported that the patient had no adverse event. The HCP (health care professional) was unaware of the precise spot of vaccine leakage and the product ran down the patient's arm during administration. Narrative amended accordingly. Follow-up report  request report) received on 17-Nov-2017: reference number (1025634) was added. As per the report 25 gauge needle was used and before vaccination needle appeared tightly attached. It was reported that leak was coming from the base of the needle and there were no signs of damage. Narrative amended accordingly. Follow-up report was received on 13-Dec-2017: Based on the investigation performed, it was concluded that FLUCELVAX (Batch number: 195229) was manufactured in compliance with the approved internal procedures an in accordance with the quality requirements. No internal root cause was identified in the manufacturing process or related to the syringes or stopper components, and no trends were identified for the batch for leaking syringes. There was no internal root cause that could be confirmed and no external/user root cause could be determined. The narrative was amended accordingly.
Age: 1.33
Sex: M
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial spontaneous case, was received on 24-Oct-2017, from other non-health professional, concerning a 01-year-old male infant. The patient had no relevant medical history and concomitant medications. On 19-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration, anatomical location, batch number: 195222, expiry date: 30-Apr-2018) and had no adverse event. The reporter assessed the event as non-serious. Significant case correction received with IRD 24-Oct-2017: One event (no adverse event) was deleted and narrative was amended accordingly. Non-significant case correction received with IRD 24-Oct-2017: Expiry date of the product was added and narrative was amended.
Age: 65.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product leakage, Product preparation error, Underdose
Clinical narrative: This initial spontaneous case received on 23-Oct-2017 from other health professional (nurse), concerning an elderly, male patient of age over 65-year-old (as reported). On 23-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: less than 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiration date: not reported). At the time of the vaccine administration, the needle was not tightened enough on the syringe and about half of the vaccine leaked out upon administration (explicitly considered as wrong injection technique, product leakage and incomplete dose administered) and patient had not experienced any adverse effects (side effects) after the vaccination. The reporter assessed this case as non-serious. Follow up received on 27-Nov-2017: New event (No adverse effect) was coded. It was reported that, the patient had not experienced any adverse effects (side effects) after the vaccination. The narrative was amended accordingly. Non-significant case correction received on 27-Nov-2017 with CRD on 08-Dec-2017: Age group (elderly) was added in the screen and narrative.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Heart rate decreased, Hyperthermia, Immobile, Loss of consciousness
Clinical narrative: This initial spontaneous case, was received from pharmacist on 01-Nov-2017, concerning a 15-year-old, adolescent female patient. The patient's concomitant medication included CEFTIN (since 24-Oct-2017). On 01-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml route of administration: intramuscular, anatomical location: left deltoid, batch number: 195229 expiry dates: May-2018. On the same day of vaccination, the patient had hyperthermic response (stated as then passed out prior to leaving pharmacy). She was conscious and immobile for 2 minutes. EMS (emergency medical support) came and assessed the patient and found blood pressure was found to 108/67 and heart rate (47) was low. It was reported that total time was 15 to 20 min before cleared to go. At the time of this report, patient recovered from the events. The reporter assessed the case as non-serious.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site pruritus, Injection site swelling, Vaccination site pain
Clinical narrative: This initial spontaneous case, was received on 25-Oct-2017, reported by other health professional, concerning a 39-year-old, adult, female patient. The patient's historical condition included pseudotumor cerebri. On 19-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195126, expiry date: Apr-2018). On the same day after vaccination, at night time, the patient felt soreness at vaccination site. On 20-Oct-2017, 1 day after the administration of vaccine, the patient experienced itchiness and was swelling at the injection site. On 23-Oct-2017, the injection site was large, bruised, was in moon-shaped area and was very itchy. No treatment medications were given to the patient. As of 24-Oct-2017, the patient recovered from itchiness, but the injection site was still swollen. The reporter assessed this case as non-serious.
Sex: U
Vaccine: FLU4
Symptoms: Death, Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The consumer posted on social media about 8 flu deaths of which, 7 had the flu shot and all 8 took THERAFLU. The consumer asked what's your take on who is to blame? This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. This case is one of the 7 cases, reported by the same reporter for same event.
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse pre scriber referring to a 23 year old patient. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. Approximately on and unspecified date in 2014 (reported as 3 and 1/2 years ago), the patient was vaccinated with the first dose of GARDASIL 9 or with GARDASIL (strength, dose, route, lot# and expiration date were not reported) for prophylaxis, as the reporter stated that it was unknown which vaccine was given to the patient. Furthermore, it was reported, that approximately on an unknown date in 2016 (reported as about 1 and 1/2 years ago), the patient received a second dose of GARDASIL 9 or with GARDASIL (also unknown which vaccine was given). No adverse events were reported.
Sex: F
Vaccine: MENB
Symptoms: Chills
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar adverse events for three patients. This is the second of three reports. An adolescent female patient of unspecified race/ethnicity received on an unknown date a single dose of TRUMENBA for immunization. Medical history and concomitant medications were not reported. Next day after vaccination, the patient experienced chills. Outcome was unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018031111 Same reporter/product/event, different patient. US-PFIZER INC-2018031093 Same reporter/product/event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Injection site reaction
Clinical narrative: This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. An adolescent patient of unspecified age and gender received TRUMENBA on an unspecified date, at single dose, for immunization. Medical history and concomitant medications were not provided. On an unspecified date they got funky side effects at the injection site but realized they needed to shake the dose vigorously and the issue resolved. Information on the batch number has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Death, Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Flu seasonal QIV Dresden. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving influenza vaccine quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to influenza vaccine quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The consumer posted on social media about 8 flu deaths of which, 7 had the flu shot and all 8 took THERAFLU. The consumer asked what's your take on who is to blame? It was unknown if an autopsy was performed or not. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. This case is one of the 7 cases, reported by the same reporter for same event.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Electroencephalogram, Irritability, Lethargy, Pyrexia, Screaming
Clinical narrative: Fever, lethargic, irritable, scream, seizures.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Seizure
Clinical narrative: Fever, lethargic, irritable, scream, seizures.
Age: 23.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: 1/10/18 vaccinated and next day with swelling seen in ED 1/11/18 Dx cellulitis Tx KEFLEX and Hydrocodone on 1/12/18 with swollen tender erythema.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Patient claims she felt pain and limited range of motion that is ongoing that she believes is caused by the immunization.
Age: 0.33
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Patient was given Hepatitis B dose 3 too early at 4 mos. old. Patient was only 4 mos. old and should not have received the vaccine until patient is 6 mos. old. Patient was not harmed in the event. Patient received extra vaccine and will be re-vaccinated when correct time is due 2/2/18, appointment scheduled.
Age: 14.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Dizziness, Respiratory distress
Clinical narrative: Client had respiratory distress and dizziness after receiving vaccine, epinephrine was administered and respiratory distress resolved. Client was transported to hospital by EMS.
Age: 24.0
Sex: F
Vaccine: FLU3, IPV, MEN, TDAP
Symptoms: Delivery, Exposure during pregnancy, Human chorionic gonadotropin increased, Meconium in amniotic fluid, Pre-eclampsia
Clinical narrative: Baby now 15 months old and "6 months ahead in development" per pedi. Pt developed preeclampsia and was induced 3 weeks early with vaginal delivery of 5# 12 oz girl with meconium. Apgars not known, but cried right away. Went to NICU for hours because small for gestational age and meconium. She has had a healthy infancy. On 10 Feb she received PCN IM, HepA HepB (TWINRIX), Adenovirus. She also had gas exposure for training.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cough, Influenza, Influenza virus test, Lethargy
Clinical narrative: Patient developed flu symptoms, fever and chills several hours after getting the vaccine. He had no prior symptoms. He had a high fever during that night and a lower grade fever through Saturday evening. He also had a sore throat and was very lethargic. His fever broke on Sunday and continued to have a sore throat. Today is Thursday and still has a cough.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pyrexia, Streptococcus test
Clinical narrative: Patient developed flu symptoms, fever and chills several hours after getting the vaccine. He had no prior symptoms. He had a high fever during that night and a lower grade fever through Saturday evening. He also had a sore throat and was very lethargic. His fever broke on Sunday and continued to have a sore throat. Today is Thursday and still has a cough.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: CLIENT RECEIVED ADULT DOSE OF VAQTA.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 03-JAN-2018, the patient was vaccinated with an expired dose of VARIVAX lot # L050560 and expiration date of 14-DEC-2017, subcutaneously for prophylaxis (dose not reported). The vaccine was reconstituted with sterile diluent (MERCK) (lot number and expiration date were not reported). No adverse effects were reported.
Sex: F
Vaccine: FLU4
Symptoms: Adverse drug reaction, Arthralgia, Gait disturbance, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from consumer on 15-Jan-2018. This case involves female patient (age reported as 61 unit unspecified) who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (frequency once, batch number, expiration date, dose and site of administration was not reported) via intramuscular route on 31 Oct 2017. The patient's medical history and concomitant medications were not reported. On 01 Nov 2017, one day following the vaccination, the patient experienced pain in her fingers, then pain in her feet and ankles. Reporter states ongoing joint pain. Patient has been to podiatrist, and to her physician, the patient was treated with prednisone which caused her had heart rate to race on an unknown date. It was also stated that the patient cannot walk some days and its hurts all over. Lab data was not reported. Corrective treatment includes prednisone. The patient had not recovered from the events. This case was reported as serious due to disability. List of documents held by sender: none.; Sender's Comments: Patient experienced pain in ankle and pain in extremity after vaccination. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Palpitations
Clinical narrative: Initial unsolicited report received from consumer on 15-Jan-2018. This case involves female patient (age reported as 61 unit unspecified) who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (frequency once, batch number, expiration date, dose and site of administration was not reported) via intramuscular route on 31 Oct 2017. The patient's medical history and concomitant medications were not reported. On 01 Nov 2017, one day following the vaccination, the patient experienced pain in her fingers, then pain in her feet and ankles. Reporter states ongoing joint pain. Patient has been to podiatrist, and to her physician, the patient was treated with prednisone which caused her had heart rate to race on an unknown date. It was also stated that the patient cannot walk some days and its hurts all over. Lab data was not reported. Corrective treatment includes prednisone. The patient had not recovered from the events. This case was reported as serious due to disability. List of documents held by sender: none.; Sender's Comments: Patient experienced pain in ankle and pain in extremity after vaccination. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Flank pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: No adverse event until 12-23-17 while driving out of town shoulders and front of sides became painful - some relief when moving arms done, then pain would come back. Pain started after driving about 10 hours, then went away. 12-28-17 pain from elbow to wrist both sides - continued.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site swelling/redness.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Skin warm
Clinical narrative: Patient developed pain in his upper left arm (injection site) later on in the day after receiving immunization. He also noticed redness that was warm to touch. The redness was not on the injection site, but below/into his under arm area. Did not spread or become itchy, did not have any respiratory issues. His only complaint was that his arm hurt. He presented to clinic x 2 days later (1/24/18).
Age: 31.0
Sex: M
Vaccine: RAB
Symptoms: Influenza like illness, Malaise, Pain, Pyrexia
Clinical narrative: Flu-like symptoms to include fever, malaise, and body aches. Individual took ibuprofen OTC when symptoms began.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Tdap on 1/10/18, patient had already received the Tdap on 11/30/2016. Patient should have not received a second dose of Tdap. No harm to patient, extra Tdap given when patient was all set for 10 yrs.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 04-JAN-2018, the patient was vaccinated with M-M-R II, intramuscularly (strength, dose, frequency, lot# and expiration date were not provided) for prophylaxis. Other suspect therapies included sterile diluent (MRK). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 04-JAN-2018, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M041085, expiration date 03-JAN-2018, subcutaneously for prophylaxis (strength and frequency were not provided).  Other suspect therapies included sterile diluent (MRK). No adverse effects reported.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a female patient who would be currently 24 year old at the time of this report. The patient had no medical history, drug reactions/allergies or concomitant medications. On 13-DEC-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot # N023952 with expiration date of 12-JUL-2020, intramuscularly as vaccination (dose not reported). On 04-JAN-2018, the patient went to the pharmacy and reported that since 13-DEC-2017 (reported as since the receipt of the vaccine), she experienced pain at the injection site, which was radiating up towards her shoulder. The reporter stated there was also a bump at the injection site (injection site mass). At the time of the report, the patient did not recover from pain, injection site mass and injection site pain. The causal relationship between the event and therapy with GARDASIL 9 was not reported.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Eczema, Injection site eczema, Injection site urticaria, Urticaria
Clinical narrative: Received the injection on the evening of the 4th, woke up the next morning with hives and eczema covering his legs, trunk, back, arms.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Dyskinesia, Heart rate irregular, Hyperhidrosis, Hypoaesthesia, Malaise
Clinical narrative: Shortly after receiving immunizations, pt complained of seeing spots and feeling numb shortly before her read rolled back and her body stiffened and jerked. Pt was extremely diaphoretic and not alert. We elevated her feet on a chair, placed cool pack on her neck, and began taking vital signs. At 1605, her right radial pulse was found to be weak and irregular at 48 bpm. Her blood pressure was 153/135, taken electronically. Pt responds to her name and complains of not feeling well and nauseous. Employee was unable to palpate a left radial pulse. Ambulance was called. At 1610, pt's right radial pulse was weak and irregular at 50 bmp and B/P was 62/32 (electronically). At 1613, pt's right radial pulse was stronger and regular at 69 bmp and manual B/P reading of 110/74 with electronic reading of 92/57. At 1615, Ambulance arrived at scene and pt was transported to local emergency department, where she was released shortly thereafter.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Musculoskeletal stiffness, Nausea, Posture abnormal, Pulse abnormal, Visual impairment
Clinical narrative: Shortly after receiving immunizations, pt complained of seeing spots and feeling numb shortly before her read rolled back and her body stiffened and jerked. Pt was extremely diaphoretic and not alert. We elevated her feet on a chair, placed cool pack on her neck, and began taking vital signs. At 1605, her right radial pulse was found to be weak and irregular at 48 bpm. Her blood pressure was 153/135, taken electronically. Pt responds to her name and complains of not feeling well and nauseous. Employee was unable to palpate a left radial pulse. Ambulance was called. At 1610, pt's right radial pulse was weak and irregular at 50 bmp and B/P was 62/32 (electronically). At 1613, pt's right radial pulse was stronger and regular at 69 bmp and manual B/P reading of 110/74 with electronic reading of 92/57. At 1615, Ambulance arrived at scene and pt was transported to local emergency department, where she was released shortly thereafter.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Throat irritation
Clinical narrative: On 1/24 patient developed a "scratchy" throat and it felt swollen. She took BENADRYL, and said she was feeling better. On 1/25 she said she felt worse.
Age: 20.0
Sex: M
Vaccine: ANTH, RAB, TYP
Symptoms: Dyspnoea, Pruritus, Throat irritation
Clinical narrative: APPROXIMATELY 25- 30 MINUTES AFTER VACCINES WERE GIVEN HE COMPLAINED OF ITCHING ON HIS BACK, ITCHY FEELING THROAT AND HARDER TO BREATHE. PATIENT WAS TAKEN TO TREATMENT ROOM AND VITALS SIGNS WERE MONITORED AND WERE WITHIN NORMAL RANGE. PATIENT SAID HE WAS FEELING BETTER AFTER APPROXIMATELY 45 MINUTES OF CONTINUOUS MONITORING AND PATIENT WAS RELEASED. PATIENT SENT TO PHARMACY TO PICK UP BENADRYL PRESCRIPTION.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Dermatitis, Eczema, Rash
Clinical narrative: Patient developed a blister and rash on the left side of her neck a couple of day after the vaccine. Now the rash is moving to the left side of her neck on 1/24/18.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Pyrexia, Rash, Swelling
Clinical narrative: Facial rash, swelling redness spread to elbow subjective fever, chills.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 03-JAN-2018, the patient was vaccinated with an expired dose of VARIVAX lot # N012619, expiration date 20-DEC-2017, for prophylaxis (strength, dose and frequency were not provided).  Other suspect therapies included sterile diluent (MRK). No adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a male patient of unknown age who was reporting on himself. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies. On 17-MAY-2017, the patient was vaccinated with the first dose of GARDASIL injection (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 14-AUG-2017, the patient received the second dose of GARDASIL injection (exact dose, route of administration, lot # and expiration date were not reported). On 23-JAN-2018, the patient was vaccinated with a dose of GARDASIL 9 (exact dose and route of administration were not reported; lot # N015087). That was the third dose of the human papillomavirus vaccine received by the patient. No adverse effects were reported.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not provided. The patient inadvertently received SHINGRIX via subcutaneous injection, which led to inappropriate route of vaccination. No further information provided. The reporter preferred not to provide further information at the time of reporting.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling
Clinical narrative: Hand swelled up. Intense pain in arm, hand, wrist and elbow.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure via skin contact, Occupational exposure to product
Clinical narrative: This initial spontaneous case, was received on 11-Aug-2017, by a pharmacist and concerns a 31 years old female patient. Patient's medical history, concomitant medications were not reported. On 09-Aug-2017, while administering FLUCELVAX QIV (dose: less than (as reported), batch number: 195214, route of administration, expiry date was not reported) to the patient, the vaccine squirted on to the face of pharmacist; as she removed syringe from the patient and was trying to dispose it and she washed her face. Outcome of the event occupational exposure while administering product was not reported. The reporter assessed the event as non-serious. Non-significant follow up received on 20-Oct-2017: The PTC (product technical complaint) reference number (1025363) was updated.
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial spontaneous case, was received on 20-Oct-2017, from other health professional, concerning a 3-year-old, female child (patient). The patient had no relevant medical history related to allergic reactions. The patient was not on any concomitant medications. On 19-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left thigh, batch number: 195125, expiry date: Apr-2018). It was reported that, the vaccine was administered to a child under 4 years of age i.e., 3-year-old patient. No adverse event was reported after vaccination. The reporter assessed this case as non-serious.