chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284752, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284754, 2018SA284750. (Same reporter). This case involves a 09 year old patient who received 0.5 ml vaccine FLUZONE QUADRIVALENT that was outside of the recommended temp range below 32 Fahrenheit. The patient's past medical history and concomitant medication were not provided. On 02-Oct-2018, the patient received a 0.5 ml dose of suspect QUADRIVALENT INFLUENZA VACCINE lot number U1997AA, expiry date 30 June 2019 via intramuscular route in the left deltoid. It was a case of actual medication error due to product storage error. It was not known whether patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 14.0
Sex: U
Vaccine: FLU4
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 10-Oct-2018 from a nurse. This case is linked to cases 2018SA284746, 2018SA284721, 2018SA284749, 2018SA284750, 2018SA284751, 2018SA284752, 2018SA284753, 2018SA284754, 2018SA284755 and 2018SA284748. (Same reporter). This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number and expiry date not reported) lot U1997AA via intramuscular route in the left deltoid on 03-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (patients were given vaccines that were outside of the recommended temp range) and Deteriorated drug administered. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA277269 (same reporter). This case involves a 4 years old patient (age not reported) who received vaccine QUADRACEL that was outside of the recommended temp range below 32 Fahrenheit. The patient's past medical history and concomitant medication were not provided. On 02-Oct-2018, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via intramuscular route in the left thigh. It was a case of actual medication error due to product storage error. It was not known whether patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, Product preparation issue
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four-months old male patient who was vaccinated with a dose of vaccine ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Oct-2018, the patient received a 0.5 ml  single dose (that nurse have mixed 2 powders with 1 diluent) of suspect HIB (PRP/T) VACCINE (lot: UI937AA (powder); expiry date: 05-Nov-2019; Lot: U60110AA (diluent) expiry date: 21-Jan-2020 and carton lot: UI937AA) via intramuscular route in the left thigh. The patient was also vaccinated with  a dose of PREVENAR 13 on an unknown date. It was a case of actual medication error due to inappropriate reconstitution technique and extra dose administered. It was unknown whether the patient experienced any adverse events. The patient mad e a visit to the doctor on 15-Oct-2018. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old male patient who received inadvertently an expired 0.5 ml dose of vaccine FLUZONE QUADRIVALENT (lot UI865AA  and expiration date 30-Jun-2018) via intramuscular route in the right thigh on 11-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves female patient (36-37 year old ) who experienced allergic reaction while he  received vaccine FLUZONE QUADRIVALENT. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2014, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and Exp. Date not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient has a documented egg allergy reported. Details of lab data not provided. Final diagnosis was allergic reaction. No information about corrective treatment reported. The event outcome was unknown. List of documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Hypoaesthesia
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 39 years old female patient who experienced chest tightness, right side of her face went numb and chest pain, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18 Oct 2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE lot number not reported. On an unknown date, five minutes post vaccination patient developed a non-serious chest tightness, right side of her face went numb, chest pain. (Other relevant tests included no lab data.) Final diagnosis was chest pain, right side of her face went numb and chest tightness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as recovered for right side of her face went numb and for chest pain and not recovered for chest tightness.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case was linked to 2018SA292533 (same reporter). This case involves an Elderly patient above 65 years who received a dose of FLUZONE HIGH DOSE (lot number not reported) via unknown route in unknown administration site but it was from last year (expired vaccine used). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of potential medication error due to expired vaccine used. It was reported that the patient did not experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient (age and gender was not reported) who was received a dose of FLUZONE QUADRIVALENT (lot number, expiry date, dose, dose in series, route and site of administration was not reported) which was slushy and was thawed and exposed to temperatures below 0 degree Celsius. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to deteriorated drug administered and incorrect product storage. The vaccine should be discarded. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Joint stiffness, Pain in jaw
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years (gender unknown) old patient who experienced jaw stiffness and jaw pain, while received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On 18-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ042AA, expiry date 19-Sep-2018 via intramuscular route in unknown administration site. On 19-Oct-2018, the patient developed a non-serious jaw stiffness (joint stiffness) on the same side as the injection, 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 19-Oct-2018, the patient developed a non-serious jaw pain (pain in jaw) on the same side as the injection, 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not provided. Final diagnosis was jaw pain and jaw stiffness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for jaw stiffness and as Unknown for jaw pain. List of documents held by sender- none.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to 2018SA292670 (same reporter). This case involves a 71-year-old male patient who was vaccinated with the dose of FLUZONE HIGH DOSE lot UJ042AB exp date: 19-May-2019, via intramuscular route in the left deltoid on 18-Oct-2018 which was administered prior to realizing a 1 day shipping excursion had occurred with the product, delayed Transit Vaccine Stability. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines administered. It is an actual medication error case due to incorrect product storage. No reaction reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 4 months old patient received both vaccines PENTACEL and HIB Vaccine. (batch number, expiry date, dose, dose in series, route and site of administration were not reported for both the vaccine). The patients past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medication was not reported. It is an actual medication case error due to extra dose administered. It was not reported that if any adverse event was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves four-months old patient who was vaccinated PENTACEL and HIB (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was actual medication error due extra dose administered. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 55.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Dry mouth, Dysstasia, Fatigue, Headache
Clinical narrative: Intensely sore muscles, core, arms, and legs. Difficulty standing. Pain in fingers when gripping. Headache. Extremely tired. Fever. Chills. Mouth was very dry.
Age: 55.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Intensely sore muscles, core, arms, and legs. Difficulty standing. Pain in fingers when gripping. Headache. Extremely tired. Fever. Chills. Mouth was very dry.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Abdominal pain, Insomnia, Malaise, Vascular pain
Clinical narrative: Patient reports insomnia accompanied with GI cramping on night one. She reports an overall feeling of illness days two thru four with GI cramping and carotid artery pain. Has an appointment for a physical next week and is following up with her doctor if still not feeling well on day of visit.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Lethargy, Lung disorder, Malaise, Pain of skin, Rhinorrhoea
Clinical narrative: Patient reported approximately 6 hours after vaccination she started to feel sick, lethargic, runny nose and sneezing. Patient stated that her skin begin to hurt to the touch. She had pain on the left side of her body in the back, ribs and pain goes from back to front and is more prominent in the back. Patient stated that her lungs felt compromised.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Sneezing
Clinical narrative: Patient reported approximately 6 hours after vaccination she started to feel sick, lethargic, runny nose and sneezing. Patient stated that her skin begin to hurt to the touch. She had pain on the left side of her body in the back, ribs and pain goes from back to front and is more prominent in the back. Patient stated that her lungs felt compromised.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Discomfort, Pain in extremity, Paraesthesia
Clinical narrative: Quickly after getting the injection I began to experience paresthesia in my left forearm, middle 3 fingers, and pain on both sides of my middle finger. The paresthesia then began to creep up my arm, across my shoulder into my neck and up the back of the left side of my head and then in the left side of my face. I also had random shooting, sharp pain in the left arm and pain if I used the arm to hold anything. This happened all by 6 PM. The paresthesia did not progress to any new areas the rest of the evening. Upon waking today, 10/25/18, the paresthesia in the arm and head is gone but the left side of my face feels very heavy. I do not notice drooping. As the morning is progressing, it is now 10 AM as I write this, the right side of my neck is having a tingling sensation and it is creeping into the right side of my face. I am also having difficulty typing with my left hand as it cramps when I use it.
Age: 33.0
Sex: M
Vaccine: HEPA
Symptoms: Chest discomfort, Feeling abnormal
Clinical narrative: Right after injection given the patient reported he didn't feel right and his chest was heavy.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Malaise, Syncope
Clinical narrative: Pt told me he wasn't feeling well as we were driving home from the doctor's office and then fainted in the car. We returned to the doctor's office where they monitored him until he was feeling normal.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a dose of the seasonal flu vaccine in our office on 10/08/18, dad called us on 10/12/18 to advise us that the patient had just received the flu vaccine again at her school. Dad stated that he had advised the school that she had already received the vaccine in our office on 10/08/18 and she wouldn't be participating in their flu clinic offered at the school, but on 10/12/18 dad found out that they had administered the flu vaccine again, dad then contacted and notified us. Patient is currently doing good per dad.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Lymphadenopathy, Pruritus, Rash pustular, Swelling
Clinical narrative: Patient noticed enlarged lymph node in left side of neck the night of Oct. 16th and forehead swelling on left side the morning of Oct. 17th. The skin over the left eyebrow broke open into blister like pustule.  The patient went to see Dr. the afternoon of Oct. 17th and was prescribed generic BACTRIM DS. After taking multiple doses of the antibiotic with no relief and continued breakout of pustules, the patient called the MD and discussed changing the medication to Acyclovir 400mg 1 TID for 10 days. The patient is continuing to have excessive itching as well as blister-like pustules on the forehead.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram head normal, Confusional state, Loss of consciousness, Muscle rigidity, Vomiting
Clinical narrative: Pt had eaten 1 hour prior to Vaccine. Pt received Vaccine w/o incident, Pt left clinic 25 min after receiving vaccine, pt ate 2 bites of a donut and slumped to the ground then went rigid for about 20 sec but was unconscious for 2 min. Pt was confused after the event and vomited twice on the way to the ED. Pt has had no problems reoccurring since the incident.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient broke up in hives after the vaccine. Had to get a BENZEDRINE shot at the hospital.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Similar reaction on previous exposure to drug
Clinical narrative: Patient described a rash that appeared on his inner arms and inner thighs the day after vaccination. The rash was elevated, patchy, and red. The rash did not itch and lasted roughly two days before subsiding. The patient noted that the reaction was similar to his reactions to penicillin, naproxen, and ibuprofen.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Abnormal behaviour, Anger, Sleep disorder, Vaccine positive rechallenge
Clinical narrative: Behavioral side effects and sleep disturbance, anger/rage which is very atypical for child starting within hours of vaccine administration. Similar reaction in previous years to flu vaccine per mom.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: L arm swelling and itching at injection site. No anaphylaxis.
Age: 42.0
Sex: F
Vaccine: FLU4, HPV9, TDAP
Symptoms: Upper respiratory tract infection
Clinical narrative: Developed URI symptoms several days after vaccination, patient was not previously ill.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: L upper extremity numbness and tingling from elbow to 5th digit on ulnar side. FROM, grip strength 5/5. Cap refill less than 3 sec. Pulses 2+. All symptoms had resolved by the following day.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of consciousness, Malaise, Road traffic accident
Clinical narrative: On the way home the patient started to fill sick, and then felt like he was going  to pass out. He did pass out and wrecked his vehicle.
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This initial spontaneous report was received from a pharmacist concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were unknown by reporter. On an unspecified date the patient was administered a dose of PNEUMOVAX 23 (Lot #, dose and route were unknown) as prophylaxis. It was reported that on an unknown date, the patient developed an unspecified "reaction" to the injection. It was unknown if the patient received treatment for the event or if there were diagnostic laboratory tests performed. It was also unknown if she sought medical attention. At the time of the report, the patient was recovering from the event. The causal relationship between PNEUMOVAX 23 and the event was related.
Sex: U
Vaccine: VARZOS
Symptoms: Product availability issue
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender reporting on itself. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unspecified date in July 2018 (reported as 3 months ago), the patient was vaccinated with the first dose of zoster vaccine live (manufacturer unknown) for prophylaxis (strength, dose, dosage schedule, route, anatomical location, lot # and expiry date were not provided). On an unspecified date approximately in 2018, the patient was due for the second shot, but it was been unable to find any provider on the area who had the vaccine. The patient reported that its doctor nor any of the local pharmacies had it. The outcome of product availability issue was not reported. The reporter's causality assessment between zoster vaccine live (manufacturer unknown) and product availability issue was not reported.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to a 15-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-OCT-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N032744, expiration date 20-NOV-2019 (also reported as 19-NOV-2020) (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 15 to 46 degrees Fahrenheit for 2 hours and 57 minutes. A digital data logger was not involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA006272.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 11 year old female patient. The patient's pertinent medical history, concurrent conditions and information about concomitant medications were not reported. On 31-AUG-2017, the patient was vaccinated with M-M-R II for prophylaxis (dose, frequency, route of administration, lot #, expiration date were not reported). And then, on 14-SEP-2017, the patient was vaccinated with VARIVAX for prophylaxis (dose, frequency, route of administration, lot #, expiration date were not reported). The vaccines was administered separately within 30 days (4 weeks). No adverse effects were reported.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case is linked to cases 2018SA292284, 2018SA292283 and 2018SA292285. This case involves a 57-year-old female patient who was vaccinated with a dose of USP FLUZONE HIGH DOSE lot UJ038AA via intramuscular route in the left deltoid on 18-Oct-2018.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines given at the time. It was an actual medication error due to Inappropriate age at vaccine administration and accidental overdose. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked with the cases 2018SA292282, 2018SA292284 and 2018SA292285 (same reporter). This case involves a 56 years old male patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ038AA and expiry date: 03-May-2019) via intramuscular route in the right deltoid on 18-Oct-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines given at the time. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA292282, 2018SA292283 and 2018SA292285. This case involves a 25 years old female patient who was accidentally vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot UJ038AA and Exp. Date 03-MAY-2019) via intramuscular route in the right deltoid on 18-Oct-2018. The patient's medical history and concomitant medications were not reported. No other vaccines given at the time. It was also an actual medication error case due to inappropriate age at vaccine administration and vaccination Overdose. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case was linked to cases 2018SA292282, 2018SA292283 and 2018SA292284 (same reporter). This case involves a 32 years old female patient who accidentally received vaccine FLUZONE HIGH DOSE along with other three patients. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No vaccine was concomitantly given during that time. On 18-Oct-2018, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, lot UJ038AA (expiry date: 03-May-2019) via intramuscular route in the left deltoid. It was also reported that one of the patients received FLUZONE QUAD  appropriately for their age but unable to report which of the patients received it at that time. It was a case of actual medication error due to inappropriate age at vaccine administration and Overdose accidental. It was unknown whether patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves female patient of unknown age who experienced headache from her head to the bottom of her neck and had a swollen gland under her armpit not on the same side where she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site. On unknown dates, the patient developed a non-serious headache from her head to the bottom of her neck and had a swollen gland under her armpit (latency was not reported) following the administration of INFLUENZA VACCINE. (Other relevant tests included No lab data.) Final diagnosis was has a swollen gland under her armpit and headache from her head to the bottom of her neck. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for headache from her head to the bottom of her neck and as Not Recovered / Not Resolved on an unknown date for had a swollen gland under her armpit.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA292656 (same reporter). This case involves a 69 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ042AB, expiration date: 19-May-2019, dose, via intramuscular route and in left deltoid) on 18-Oct-2018. The patient's medical history and concomitant medications were not reported. No other vaccine was administered. It was an actual medication error due to incorrect product storage (administered prior to realizing a one day shipping excursion had occurred with the product, Delayed Transit Vaccine Stability, no reaction reported). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid serious case received from a physician. This case involves a 60 years old female patient who was administered one dose of TENIVAC, when she was meant to receive ADACEL and INFLUENZA VACCINE. The patient's past medical history, medical treatments, vaccinations and family history were not provided. On 22-Oct-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U5526AA via unknown route in the left deltoid. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. It was as actual medication error due to wrong drug administered. It was reported that no adverse reactions were found. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: DTAPIPV, HPVX, MEN, VARCEL
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 11 year female patient who received QUADRACEL (batch number C5248AA, expiry date 21 Aug 2019, intramuscularly via right arm) instead of PENTACEL on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA VACCINE for Immunisation; MENINGOCOCCAL C VACCINE for Immunisation; and HPV VACCINE for Immunisation. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3
Symptoms: Underdose, Wrong technique in product usage process
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves unknown age of female patient for whom something wrong with the technique when the FLUZONE HD was administered and some of the vaccine squirted out was reported, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, lot number not reported via unknown route in unknown administration site. It was reported that FLUZONE HD administered to a patient at another facility who stated there was something wrong with the technique when the FLUZONE HD was administered (wrong technique in product usage process) and some of the vaccine squirted out (underdose) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not reported. Final diagnosis was some of the vaccine squirted out and something wrong with the technique when the FLUZONE HD was administered. It was unknown whether patient experienced any adverse reaction after vaccination. Outcome of the event was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal distension, Flatulence, Rhinorrhoea, Throat clearing
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years and seven months old female patient who experienced clearing her throat, sniffling and stomach bloating and gas, while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ005AD; expiry date: 30-Jun-2019 via intramuscular route in the left upper thigh. On an unknown date, the patient developed a non-serious clearing her throat, sniffling and stomach bloating and gas following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. No lab data reported. Final diagnosis was stomach bloating and gas, sniffling and clearing her throat. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as Unknown. Additional information was received from consumer on 22-Oct-2018. Product coding was updated in field and narrative. List of documents held by sender- none.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient is a 15 year old female with a history of asymptomatic acute cystitis and restrictive eating behaviors with concern for possible eating disorder. Pt received flu vaccine and lab work and had syncopal event for less than 5 sec. while in office. Then pt transferred to ER via EMS (concern vasovagal vs adverse reaction to vaccine).
Age: 52.0
Sex: F
Vaccine: FLUR4
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node Lt Supraclavicular (trapezoid) Similar Sxs with past flu shot 2 years ago.
Age: 51.0
Sex: F
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Rash, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: I had a patient present with a red, itchy, "angry" looking rash on both her legs which she described as effecting her from the waist down and feels like she's wearing "wool pants". Patient came in wearing shorts due to not being able to wear pants. On 10/2, the patient was given FLUCELVAX, PNEUMOVAX 23 and first dose of SHINGRIX. Per patient, the next day she had the above mentioned rash "from head to toe". She had prednisone from a previous condition and took that plus Motrin and the rash resolved for "about a week". On Monday of this week, the rash reoccurred on the patient's legs. She presented to the pharmacy asking what the cause was, do we have anything OTC that can be recommended and what should she do. I called GSK and spoke with a representative. She asked many questions regarding the case (no HIPPA information was released) and then told me that she would have to have me speak to a PharmD on staff. However, they are experiencing a higher than normal call volume and they would have to call me back (as of the sending of the email, they have not contacted me). A similar situation occurred when reaching out to Merck. I was on hold without reaching anyone. I also contacted the patient's doctor who recommended that due to the length of time (20 + days) that she should go to ER immediately. I gave the patient this information and recommended that she go to the ER immediately. She said had been there a month ago and incurred a $1500 bill and could not afford to go. I urged her to go repeatedly. She inquired if there was an OTC to help with the rash. I said without knowing the exact cause and with the severity of the rash that I would not recommend anything except an ER visit. She asked me if I would contact her when and if I heard back from GSK and Merck. I agreed.  She then left the store.
Age: 59.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Vaccination error
Clinical narrative: No adverse reaction occured however this was a vaccine error due to the fact that the patient was immunocompromised on Humira and received a live vaccine. 3 weeks after vaccine administration patient still had no rash, fever, or other adverse symptoms.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Blood pressure increased, Feeling cold, Heart rate increased, Myalgia
Clinical narrative: High fever, muscle and joint pain, increased blood pressure 180/91, increased heart rate 97, chills. Duration about 12 hours. No treatment. Effects diminished overnight.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: High fever, muscle and joint pain, increased blood pressure 180/91, increased heart rate 97, chills. Duration about 12 hours. No treatment. Effects diminished overnight.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Dizziness, Electroencephalogram normal, Feeling abnormal, Hyperhidrosis
Clinical narrative: Employee states she felt "dizzy", "sweaty" and "faint" about 3 hours after being vaccinated. She also reported "seeing black spots".
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Nuclear magnetic resonance imaging normal, Visual impairment
Clinical narrative: Employee states she felt "dizzy", "sweaty" and "faint" about 3 hours after being vaccinated. She also reported "seeing black spots".
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Local reaction, Pain, Swelling
Clinical narrative: Local reaction left arm: pain, swelling, redness, heat.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Neck pain
Clinical narrative: Pain in lymph nodes (swollen), pain in neck and back of head.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Herpes zoster, Mass, Rash, Rash erythematous
Clinical narrative: Pain in lymph nodes (swollen), pain in neck and back of head.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient described a rash that appeared on his inner arms and inner thighs the day after vaccination. The rash was elevated, patchy, and red. The rash did not itch and lasted roughly two days before subsiding. The patient noted that the reaction was similar to his reactions to penicillin, naproxen, and ibuprofen.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Product administered at inappropriate site
Clinical narrative: Pts. stated he received the Flu shot to high in his arm, and now he can not raise his right arm above his elbow. The Pt came into the pharmacy on 10/22/2018 after receiving the vaccination on 09/25/2018 to report the event to us.