chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Nausea, Oedema peripheral, Peripheral swelling, Tenderness
Clinical narrative: Patient noticed at noon of 9/30/2020that her left arm became swollen, it extended to underneath the arm ,armpit was swollen and tended. Pt had a headache at night and nausea. She took Tylenol and iced the area. She felt better .
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient reports extreme pain for about a week after vaccine administration that has subsided but continued through day of this report.
Age: 1.0
Sex: M
Vaccine: MMRV, DTAPIPVHIB, FLU4, HEPA, MMRV, PNC13
Symptoms: Irritability, Pruritus, Rash, Rash erythematous, Rash vesicular
Clinical narrative: 10/1/2020 MOC noticed a slight red rash on chest and arms of child. No fever, did not seem bothered by it.  Saw a PNP and was told that it might be a reaction to his MMRV vaccination given on 9/21/2020. 10/2/2020 Child woke up completely covered in a rash, described as small red blisters and some welts, itchy, "even behind his ears", "over every inch of his body". No fever, but child irritable and scratching at rash.  Saw Dr. and was told that it was most likely chicken pox.  Instructed to give Benedryl for the itching, and to use calamine lotion, after a warm bath with oatmeal. MOC currently doing all the recommended treatment, but verbalized frustration with this happening.
Age: 1.0
Sex: M
Vaccine: MMRV, DTAPIPVHIB, FLU4, HEPA, MMRV, PNC13
Symptoms: Scratch, Urticaria, Varicella post vaccine
Clinical narrative: 10/1/2020 MOC noticed a slight red rash on chest and arms of child. No fever, did not seem bothered by it.  Saw a PNP and was told that it might be a reaction to his MMRV vaccination given on 9/21/2020. 10/2/2020 Child woke up completely covered in a rash, described as small red blisters and some welts, itchy, "even behind his ears", "over every inch of his body". No fever, but child irritable and scratching at rash.  Saw Dr. and was told that it was most likely chicken pox.  Instructed to give Benedryl for the itching, and to use calamine lotion, after a warm bath with oatmeal. MOC currently doing all the recommended treatment, but verbalized frustration with this happening.
Age: 1.0
Sex: M
Vaccine: MMRV, DTAPIPVHIB, FLU4, HEPA, MMRV, PNC13
Symptoms: Rash macular, Rash papular, Rash pruritic
Clinical narrative: 10/1/2020 MOC noticed a slight red rash on chest and arms of child. No fever, did not seem bothered by it.  Saw a PNP and was told that it might be a reaction to his MMRV vaccination given on 9/21/2020. 10/2/2020 Child woke up completely covered in a rash, described as small red blisters and some welts, itchy, "even behind his ears", "over every inch of his body". No fever, but child irritable and scratching at rash.  Saw Dr. and was told that it was most likely chicken pox.  Instructed to give Benedryl for the itching, and to use calamine lotion, after a warm bath with oatmeal. MOC currently doing all the recommended treatment, but verbalized frustration with this happening.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Vaccine Administration Error: I was given the High Dose Fluzone vaccine for 2019/2020, which expired on 6/30/20, instead of the High Dose Fluzone vaccine for 2020/2021.  About 1-2 hours after I was given the vaccine, I received a telephone call from  the woman who had administered it to me, to tell me she had given me the wrong vaccine and that I needed to come back for the proper vaccine.  I was astonished, of course, and questioned how this could happen.  She admitted she had not checked the vaccine before she gave it to me.  I also asked why in the world they still had the 2019/2020 vaccine in their office, and she had no answer.  She told me she had checked with the director of the Pharmacy, and was told that it was safe for me to come back in for the proper vaccine.  However, I have lost trust in this clinic now.  I called my pharmacist, who suggested I wait 2 weeks for the proper vaccine just to be safe, which I am doing.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Father of patient called pharmacy the day after his daughter got a flu shot. Reports a Bulls-eye shaped rash around injection site, hot to the touch and itching. Patient is otherwise feeling fine.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Rash to torso and face
Age: 72.0
Sex: F
Vaccine: FLU4, TD
Symptoms: Asthenia, Chills, Heart rate increased, Insomnia, Nasal congestion
Clinical narrative: Patient developed wheezing and stuffy nose about 2 hours after the TD and high dose Flu shot. She states it is not unusual to have stuffy nose and wheezing for her after the flu shot. This was her first dose of the high dose flu shot, previously received regular flu shot. 9/25 pm, when went to lay down for bed, pulse felt like it was racing, like had a cup of coffee. She checked pulse and it was 88. Denies any palpitations. She was up and feeling wide awake until about 3 am. All day Saturday, she felt feverish, chilled, body aches, no energy. She took Tylenol every 4 hours or so. Went to bed and woke up feeling better by Sunday. Symptoms fully resolved and did not reoccur within 48 hours of the 2 vaccines.
Age: 72.0
Sex: F
Vaccine: FLU4, TD
Symptoms: Pain, Pyrexia, Wheezing
Clinical narrative: Patient developed wheezing and stuffy nose about 2 hours after the TD and high dose Flu shot. She states it is not unusual to have stuffy nose and wheezing for her after the flu shot. This was her first dose of the high dose flu shot, previously received regular flu shot. 9/25 pm, when went to lay down for bed, pulse felt like it was racing, like had a cup of coffee. She checked pulse and it was 88. Denies any palpitations. She was up and feeling wide awake until about 3 am. All day Saturday, she felt feverish, chilled, body aches, no energy. She took Tylenol every 4 hours or so. Went to bed and woke up feeling better by Sunday. Symptoms fully resolved and did not reoccur within 48 hours of the 2 vaccines.
Age: 11.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Cold sweat, Pallor, Syncope
Clinical narrative: CHILD'S SKIN  BECAME PALE , COOL AND CLAMMY, AND FAINTED WITHIN I MINUTE OF RECEIVING  ABOVE VACCINES.  NURSE LOWERED HIM TO THE FLOOR AND PLACED COOL CLOTH ON FORWARD AND BACK OF NECK.  NO INJURIES NOTED.  ASSISTED HIM TO EXAM TABLE TO LAY DOWN FOR 10 MINUTES .  HE REMAINED ON THE EXAM TABLE APPROXIMATELY 15 MINUTES WITH SUPERVISION.  HE WAS GIVEN JUICE.  SKIN COLOR RETURNED TO NORMAL.  HE WAS ABLE TO AMBULATE INDEPENDENTLY TO THE CAR TO DEPART. NURSE ACCOMPANIED HIM TO WITNESS HE WAS ABLE TO GET INTO THE CAR WITHOUT INJURY.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Persistent generalized upper arm soreness lasting greater than 16 days with mild limitation to range of motion.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Dizziness, Gait disturbance, Impaired driving ability, Labyrinthitis, Nausea
Clinical narrative: Commencing 12 hours after injections (which were given 30 minutes apart), I had intractable dizziness, vertigo, some nausea.  It has coninued for a week, I am still dizzy, unable to drive, walk or go down stairs without help.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Vertigo
Clinical narrative: Commencing 12 hours after injections (which were given 30 minutes apart), I had intractable dizziness, vertigo, some nausea.  It has coninued for a week, I am still dizzy, unable to drive, walk or go down stairs without help.
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray normal, Computerised tomogram normal, Electroencephalogram abnormal, Intensive care, Laboratory test
Clinical narrative: See attached page 9/28/2020, admitted to intensive care at Medical Center CT - no-acute abnormality MRI with and without contrast - normal Lumbar Puncture - negative EEG on 9/30 - Abnormal COVID 19 - negative CXR - negative labs drawn
Sex: F
Vaccine: FLU4
Symptoms: Lumbar puncture normal, Magnetic resonance imaging normal, SARS-CoV-2 test negative, Scan with contrast normal
Clinical narrative: See attached page 9/28/2020, admitted to intensive care at Medical Center CT - no-acute abnormality MRI with and without contrast - normal Lumbar Puncture - negative EEG on 9/30 - Abnormal COVID 19 - negative CXR - negative labs drawn
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis (L) arm inferior to area of vaccination - giving Keflex 500 mg T cap 2xd for 7 days. (10/2/20)
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Tenderness; Hurting after Shingrix administration.; Ocular migraine; skull cap headache; headache; Chills; Not feeling well; Feeling horrible; Pain in arm; Nausea; Profuse sweating; yelling in her sleep; Redness / of arm at injection site; harness of arm at injection site; Itching; This case was reported by a nurse and described the occurrence of chills in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic migraine.   On 16th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2020, 24 hrs after receiving Shingrix, the patient experienced chills, feeling unwell, feels awful, pain in arm, nausea, sweating, sleep talking, injection site erythema, injection site induration, pruritus and headache. On an unknown date, the patient experienced tenderness, pain, ophthalmic migraine and migraine. The patient was treated with naproxen (Aleve) and paracetamol (Tylenol). On 23rd September 2020, the outcome of the chills, feeling unwell, feels awful, pain in arm, nausea, sweating, sleep talking, injection site induration and pruritus were recovered/resolved. On 27th September 2020, the outcome of the ophthalmic migraine was recovered/resolved. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the tenderness, pain and migraine were unknown and the outcome of the headache was recovered/resolved.   The reporter considered the chills, feeling unwell, feels awful, pain in arm, nausea, sweating, sleep talking, injection site erythema, injection site induration and pruritus to be related to Shingrix. It was unknown if the reporter considered the tenderness, pain, headache, ophthalmic migraine and migraine to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that a little over 24 hours later after received Shingrix she began to experience multiple symptoms including chills, not feeling well, feeling horrible, pain in arm, nausea, profuse sweating, yelling in her sleep, redness and harness of arm at injection site and itching. Lot and Expiry date were unknown. Nurse stated that the patient also experienced tenderness, hurting after Shingrix administration.  She also experienced headache 24 hours after receiving Shingrix and that it was intermittent and resolved by Monday.  Headache was relieved by Aleve and Tylenol. She also experienced an ocular migraine that started Thursday and was gone by Sunday.  It was like a skull cap headache.  She's experienced Ocular migraines in the past but never had a severe migraine. The reporter consented to follow up. The case had been linked with US2020190562 same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020190557:same reporter US-GLAXOSMITHKLINE-US2020190562:same reporter
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Malaise, Migraine, Migraine with aura
Clinical narrative: Tenderness; Hurting after Shingrix administration.; Ocular migraine; skull cap headache; headache; Chills; Not feeling well; Feeling horrible; Pain in arm; Nausea; Profuse sweating; yelling in her sleep; Redness / of arm at injection site; harness of arm at injection site; Itching; This case was reported by a nurse and described the occurrence of chills in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic migraine.   On 16th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2020, 24 hrs after receiving Shingrix, the patient experienced chills, feeling unwell, feels awful, pain in arm, nausea, sweating, sleep talking, injection site erythema, injection site induration, pruritus and headache. On an unknown date, the patient experienced tenderness, pain, ophthalmic migraine and migraine. The patient was treated with naproxen (Aleve) and paracetamol (Tylenol). On 23rd September 2020, the outcome of the chills, feeling unwell, feels awful, pain in arm, nausea, sweating, sleep talking, injection site induration and pruritus were recovered/resolved. On 27th September 2020, the outcome of the ophthalmic migraine was recovered/resolved. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the tenderness, pain and migraine were unknown and the outcome of the headache was recovered/resolved.   The reporter considered the chills, feeling unwell, feels awful, pain in arm, nausea, sweating, sleep talking, injection site erythema, injection site induration and pruritus to be related to Shingrix. It was unknown if the reporter considered the tenderness, pain, headache, ophthalmic migraine and migraine to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that a little over 24 hours later after received Shingrix she began to experience multiple symptoms including chills, not feeling well, feeling horrible, pain in arm, nausea, profuse sweating, yelling in her sleep, redness and harness of arm at injection site and itching. Lot and Expiry date were unknown. Nurse stated that the patient also experienced tenderness, hurting after Shingrix administration.  She also experienced headache 24 hours after receiving Shingrix and that it was intermittent and resolved by Monday.  Headache was relieved by Aleve and Tylenol. She also experienced an ocular migraine that started Thursday and was gone by Sunday.  It was like a skull cap headache.  She's experienced Ocular migraines in the past but never had a severe migraine. The reporter consented to follow up. The case had been linked with US2020190562 same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020190557:same reporter US-GLAXOSMITHKLINE-US2020190562:same reporter
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pruritus, Sleep talking
Clinical narrative: Tenderness; Hurting after Shingrix administration.; Ocular migraine; skull cap headache; headache; Chills; Not feeling well; Feeling horrible; Pain in arm; Nausea; Profuse sweating; yelling in her sleep; Redness / of arm at injection site; harness of arm at injection site; Itching; This case was reported by a nurse and described the occurrence of chills in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic migraine.   On 16th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2020, 24 hrs after receiving Shingrix, the patient experienced chills, feeling unwell, feels awful, pain in arm, nausea, sweating, sleep talking, injection site erythema, injection site induration, pruritus and headache. On an unknown date, the patient experienced tenderness, pain, ophthalmic migraine and migraine. The patient was treated with naproxen (Aleve) and paracetamol (Tylenol). On 23rd September 2020, the outcome of the chills, feeling unwell, feels awful, pain in arm, nausea, sweating, sleep talking, injection site induration and pruritus were recovered/resolved. On 27th September 2020, the outcome of the ophthalmic migraine was recovered/resolved. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the tenderness, pain and migraine were unknown and the outcome of the headache was recovered/resolved.   The reporter considered the chills, feeling unwell, feels awful, pain in arm, nausea, sweating, sleep talking, injection site erythema, injection site induration and pruritus to be related to Shingrix. It was unknown if the reporter considered the tenderness, pain, headache, ophthalmic migraine and migraine to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that a little over 24 hours later after received Shingrix she began to experience multiple symptoms including chills, not feeling well, feeling horrible, pain in arm, nausea, profuse sweating, yelling in her sleep, redness and harness of arm at injection site and itching. Lot and Expiry date were unknown. Nurse stated that the patient also experienced tenderness, hurting after Shingrix administration.  She also experienced headache 24 hours after receiving Shingrix and that it was intermittent and resolved by Monday.  Headache was relieved by Aleve and Tylenol. She also experienced an ocular migraine that started Thursday and was gone by Sunday.  It was like a skull cap headache.  She's experienced Ocular migraines in the past but never had a severe migraine. The reporter consented to follow up. The case had been linked with US2020190562 same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020190557:same reporter US-GLAXOSMITHKLINE-US2020190562:same reporter
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Tenderness; Hurting after Shingrix administration.; Ocular migraine; skull cap headache; headache; Chills; Not feeling well; Feeling horrible; Pain in arm; Nausea; Profuse sweating; yelling in her sleep; Redness / of arm at injection site; harness of arm at injection site; Itching; This case was reported by a nurse and described the occurrence of chills in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic migraine.   On 16th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2020, 24 hrs after receiving Shingrix, the patient experienced chills, feeling unwell, feels awful, pain in arm, nausea, sweating, sleep talking, injection site erythema, injection site induration, pruritus and headache. On an unknown date, the patient experienced tenderness, pain, ophthalmic migraine and migraine. The patient was treated with naproxen (Aleve) and paracetamol (Tylenol). On 23rd September 2020, the outcome of the chills, feeling unwell, feels awful, pain in arm, nausea, sweating, sleep talking, injection site induration and pruritus were recovered/resolved. On 27th September 2020, the outcome of the ophthalmic migraine was recovered/resolved. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the tenderness, pain and migraine were unknown and the outcome of the headache was recovered/resolved.   The reporter considered the chills, feeling unwell, feels awful, pain in arm, nausea, sweating, sleep talking, injection site erythema, injection site induration and pruritus to be related to Shingrix. It was unknown if the reporter considered the tenderness, pain, headache, ophthalmic migraine and migraine to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that a little over 24 hours later after received Shingrix she began to experience multiple symptoms including chills, not feeling well, feeling horrible, pain in arm, nausea, profuse sweating, yelling in her sleep, redness and harness of arm at injection site and itching. Lot and Expiry date were unknown. Nurse stated that the patient also experienced tenderness, hurting after Shingrix administration.  She also experienced headache 24 hours after receiving Shingrix and that it was intermittent and resolved by Monday.  Headache was relieved by Aleve and Tylenol. She also experienced an ocular migraine that started Thursday and was gone by Sunday.  It was like a skull cap headache.  She's experienced Ocular migraines in the past but never had a severe migraine. The reporter consented to follow up. The case had been linked with US2020190562 same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020190557:same reporter US-GLAXOSMITHKLINE-US2020190562:same reporter
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Hyperpyrexia, Laboratory test normal, Pyrexia
Clinical narrative: fevers for the last 4 months and the highest was 104; Initial information received on 25-Sep-2020 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves a 12-month-old male patient who experienced fevers for the last 4 months and the highest was 104 (hyperpyrexia), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  On 15-May-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious fevers for the last 4 months and the highest was 104 (hyperpyrexia) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. This event was assessed as medically significant.  It was reported that the reporter thinks there may be something in the vaccine that has caused her son to have fevers for the last 4 months, the highest was 104. Currently the patient not having and elevated fevers. They visited to seven doctors for testing and all the results were normal.    On 15-Sep-2020, the patient received another 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  Relevant laboratory test results included: Body temperature - On an unknown date:  [104] Laboratory test - On an unknown date:  [Normal]  It was not reported if the patient received any corrective treatment.  On an unknown date, event outcome was not reported (unknown).  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a 12-month-old male patient who experienced hyperpyrexia following the vaccination with PENTACEL. The time to onset is unknown. However, the patient's medical history, concomitant medications, condition at time of vaccination and lab data ruling out other etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15 year old was accidentally given a Flublok vaccine, no AE; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 15 years old male patient who was vaccinated 0.5 ml of suspect with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number QFAA2014 Expiration date: 30-Jun-2021) accidentally via intramuscular route in the left arm for prophylactic vaccination on 25-Sep-2020 (PT:product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitants were given to patient.  It was an actual medication error case due to inappropriate age at vaccine administration (Same day latency).  Patient has not experienced any Adverse Events as a result of this  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: 15.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 15 year old patient was administered Flublok Quadrivalent, No AE; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 15 years old patient (gender unspecified) who was administered a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unknown date (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was 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.  There will be no information available on lot number.
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Flublok Quadrivalent from 2019-2020 formula was still in fridge and patient was administered with expired Flublok quadrivalent with no adverse event; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional in the United States.  This case involves a 75 years old female patient who received 0.5 ml once expired of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QSAA1960, expiry date: 30-Jun-2020) via intramuscular route in the deltoid on 17-Sep-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to the expired vaccine used.  At the time of report, no adverse event was 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.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus
Clinical narrative: EE received flu shot on the L arm this morning at 9:21 am. Approx. 11:30 am EE experienced itchiness on the back of the neck on the L, then L fingers, then L arm. Sensation resolved approximately 10 minutes later at 11:40 am. EE reports similar Sx with some foods without other complication.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Hyperhidrosis, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Woke up at 2AM the next day with a temp of 101.0 F, pain all over my body-joints, muscles and injection site was red, swollen and hot. I took acetaminophen and ibuprofen. I noticed a slight improvement but when these meds wore off I was back to the adverse reactions. In the following days I stayed the same except I started profusely sweating. Now is day 8 and my arm of the injection site continues to hurt. I cannot reach or hold anything. I read all the info about the Fluad 65+ vaccine. I should never have ANY VACCINE with SQUALENE!
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site warmth, Myalgia, Pain, Pain in extremity
Clinical narrative: Woke up at 2AM the next day with a temp of 101.0 F, pain all over my body-joints, muscles and injection site was red, swollen and hot. I took acetaminophen and ibuprofen. I noticed a slight improvement but when these meds wore off I was back to the adverse reactions. In the following days I stayed the same except I started profusely sweating. Now is day 8 and my arm of the injection site continues to hurt. I cannot reach or hold anything. I read all the info about the Fluad 65+ vaccine. I should never have ANY VACCINE with SQUALENE!
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Cold sweat, Headache, Lethargy, Nausea
Clinical narrative: 100.5 degree fever for 20 hours. Nausea, light vomiting. Chills, cold sweats. general lethargy. Headache, all for about 24 hours. Patient recovering nicely since.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Vomiting
Clinical narrative: 100.5 degree fever for 20 hours. Nausea, light vomiting. Chills, cold sweats. general lethargy. Headache, all for about 24 hours. Patient recovering nicely since.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient woke up with an itchy red rash on her left arm and torso on 10/2/20. She stated this was the first day it ha started since she had gotten the vaccination and that she had not changed any personal care products that would have left her with a rash. I instructed her to take an antihistamine and use OTC hydrocortisone and ice to relieve itching. She stated she was going to call her dermatologist to see if they would see her because the itching was bothering her.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Furuncle, Pain, Swelling
Clinical narrative: very painful and caused a boil type reaction, red and swollen
Age: 57.0
Sex: U
Vaccine: UNK
Symptoms: Cold sweat, Condition aggravated, Diarrhoea, Erythema, Head discomfort
Clinical narrative: NOTE:   Pharmacy received and gave 2020/2021 flu vaccine.  I was not given lot numbers or manufacturer.  1.  Two hours after shot, I had SLE rash and redness on my cheeks.  2. Within 4 hours after shot, I had hard, swollen red face tissue like hot frostbite near the SLE rash on my cheek. 3.  Within 24 hours after shot, my entire face was bright red, and my skin was clammy, but my temp stayed 98 F. 4.  I had painful headaches with pressure. 5.   Also within 24 hours, and for 2 days, I was vomiting and could not keep water or food down, and had some diarrhea.  I did NOT have any stomach pain, and had no other flu symptoms. 6.  Third Day after shot:   I woke up with pain in my right thigh that wouldn't go away, with a red rash that has been consistent in the past of x-rayed and diagnosed blood clots.  I again felt clammy and nauseated.  I treated with an extra aspirin, as my primary care was out today, and my Rheumatologist does not have time.  I was reluctant to go to ER for blood clot xray, as taking a chance on the blood clot was less of a threat than contracting COVID-19, given the spike in outbreaks.  Up through the day before the flu shot I had no symptoms and, as mentioned my immune system has been incredibly strong for the past 4 years.  I work full-time, and run 20 miles a week, including the night before the flu shot.  I have not had any of these symptoms for 4 years, before I was put on Plaquenil.  Because of the SLE rash, and red hard tissue 2 hours after the flu shot, and also because of the apparent blood clot, these are all indicators of a SLE flare-up for me that I have not had for 4 years.  Because of this, I believe that SLE, and APS secondary to SLE patients need to be cautioned on the flu virus.   There are about 100,000 SLE patients in this country, and 1/3 have APS secondary to SLE.  If those other SLE patients are not as healthy as I have been, if they have a SLE flare to the 2020/2021 flu vaccine like I did, they may have life-threatening organ damage/failure that would force them to seek ER.  If so, open beds is about nil right now.  Also, those other SLE (with APS) patients may not survive being in the hospital if they contract COVID-19 there.  It is also worth mentioning that I have never had a SLE flare with a flu shot before.  Although it may not matter, I also received a TB shot and booster 2/2020 with no adverse side affects.
Age: 57.0
Sex: U
Vaccine: UNK
Symptoms: Headache, Induration, Nausea, Pain in extremity, Rash
Clinical narrative: NOTE:   Pharmacy received and gave 2020/2021 flu vaccine.  I was not given lot numbers or manufacturer.  1.  Two hours after shot, I had SLE rash and redness on my cheeks.  2. Within 4 hours after shot, I had hard, swollen red face tissue like hot frostbite near the SLE rash on my cheek. 3.  Within 24 hours after shot, my entire face was bright red, and my skin was clammy, but my temp stayed 98 F. 4.  I had painful headaches with pressure. 5.   Also within 24 hours, and for 2 days, I was vomiting and could not keep water or food down, and had some diarrhea.  I did NOT have any stomach pain, and had no other flu symptoms. 6.  Third Day after shot:   I woke up with pain in my right thigh that wouldn't go away, with a red rash that has been consistent in the past of x-rayed and diagnosed blood clots.  I again felt clammy and nauseated.  I treated with an extra aspirin, as my primary care was out today, and my Rheumatologist does not have time.  I was reluctant to go to ER for blood clot xray, as taking a chance on the blood clot was less of a threat than contracting COVID-19, given the spike in outbreaks.  Up through the day before the flu shot I had no symptoms and, as mentioned my immune system has been incredibly strong for the past 4 years.  I work full-time, and run 20 miles a week, including the night before the flu shot.  I have not had any of these symptoms for 4 years, before I was put on Plaquenil.  Because of the SLE rash, and red hard tissue 2 hours after the flu shot, and also because of the apparent blood clot, these are all indicators of a SLE flare-up for me that I have not had for 4 years.  Because of this, I believe that SLE, and APS secondary to SLE patients need to be cautioned on the flu virus.   There are about 100,000 SLE patients in this country, and 1/3 have APS secondary to SLE.  If those other SLE patients are not as healthy as I have been, if they have a SLE flare to the 2020/2021 flu vaccine like I did, they may have life-threatening organ damage/failure that would force them to seek ER.  If so, open beds is about nil right now.  Also, those other SLE (with APS) patients may not survive being in the hospital if they contract COVID-19 there.  It is also worth mentioning that I have never had a SLE flare with a flu shot before.  Although it may not matter, I also received a TB shot and booster 2/2020 with no adverse side affects.
Age: 57.0
Sex: U
Vaccine: UNK
Symptoms: Rash erythematous, Swelling face, Systemic lupus erythematosus rash, Vomiting
Clinical narrative: NOTE:   Pharmacy received and gave 2020/2021 flu vaccine.  I was not given lot numbers or manufacturer.  1.  Two hours after shot, I had SLE rash and redness on my cheeks.  2. Within 4 hours after shot, I had hard, swollen red face tissue like hot frostbite near the SLE rash on my cheek. 3.  Within 24 hours after shot, my entire face was bright red, and my skin was clammy, but my temp stayed 98 F. 4.  I had painful headaches with pressure. 5.   Also within 24 hours, and for 2 days, I was vomiting and could not keep water or food down, and had some diarrhea.  I did NOT have any stomach pain, and had no other flu symptoms. 6.  Third Day after shot:   I woke up with pain in my right thigh that wouldn't go away, with a red rash that has been consistent in the past of x-rayed and diagnosed blood clots.  I again felt clammy and nauseated.  I treated with an extra aspirin, as my primary care was out today, and my Rheumatologist does not have time.  I was reluctant to go to ER for blood clot xray, as taking a chance on the blood clot was less of a threat than contracting COVID-19, given the spike in outbreaks.  Up through the day before the flu shot I had no symptoms and, as mentioned my immune system has been incredibly strong for the past 4 years.  I work full-time, and run 20 miles a week, including the night before the flu shot.  I have not had any of these symptoms for 4 years, before I was put on Plaquenil.  Because of the SLE rash, and red hard tissue 2 hours after the flu shot, and also because of the apparent blood clot, these are all indicators of a SLE flare-up for me that I have not had for 4 years.  Because of this, I believe that SLE, and APS secondary to SLE patients need to be cautioned on the flu virus.   There are about 100,000 SLE patients in this country, and 1/3 have APS secondary to SLE.  If those other SLE patients are not as healthy as I have been, if they have a SLE flare to the 2020/2021 flu vaccine like I did, they may have life-threatening organ damage/failure that would force them to seek ER.  If so, open beds is about nil right now.  Also, those other SLE (with APS) patients may not survive being in the hospital if they contract COVID-19 there.  It is also worth mentioning that I have never had a SLE flare with a flu shot before.  Although it may not matter, I also received a TB shot and booster 2/2020 with no adverse side affects.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Patient developed a rash on her elbow the day after immunization.  She states it is warm to the touch and itches.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: SWELLING OF ENTIRE ARM, PAINFUL, REDNESS
Age: 90.0
Sex: F
Vaccine: FLUA4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient experienced severe arm pain from her shoulder to her hand for 5-6 days. She said she felt paralyzed and could not use her hand for even simple tasks. She was advised to use tylenol and ice. After day 5 she was feeling much better and day 6 back to normal.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site redness/swelling; home care advice provided, will follow up tomorrow for clinic visit if not improving
Age: 1.25
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Menactra immunization given instead of PCV13 which was scheduled
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, VARCEL
Symptoms: Blood glucose increased, Dyskinesia, Hyporesponsive to stimuli, Pyrexia, Seizure like phenomena
Clinical narrative: Pt spiked a fever overnight on 10/1/2020.  He began with seizure like activity that last for 5 minutes.  Pt's arms were jerking, eyes were fixed forward.  EMS arrived but seizure was over.  Pt was sleepy and less responsive that usual after episode.  Pt was given a Tylenol suppository  and EMS obtained a hell stick glucose which was 130.  Parents declined  transport to the ER.  FEver came down quickly with Tylenol.  He slept well afterward and woke up happy, hungry, and active this morning.  daw
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, VARCEL
Symptoms: Somnolence, Staring
Clinical narrative: Pt spiked a fever overnight on 10/1/2020.  He began with seizure like activity that last for 5 minutes.  Pt's arms were jerking, eyes were fixed forward.  EMS arrived but seizure was over.  Pt was sleepy and less responsive that usual after episode.  Pt was given a Tylenol suppository  and EMS obtained a hell stick glucose which was 130.  Parents declined  transport to the ER.  FEver came down quickly with Tylenol.  He slept well afterward and woke up happy, hungry, and active this morning.  daw
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Fatigue, Feeling cold
Clinical narrative: Person received vaccine around 8:30AM. Reported that she was shivering uncontrollably and her body turned ice cold starting that evening into next morning. Also feeling weak and fatigued that morning.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Milde Fever, Chills, Body Aches, Fatigue
Age: 48.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Fever began around 1:30AM CST on 9/26/2020 and continued until it broke around 2:30AM CST on 9/28/2020.  This fever was as high as 103.3 at one point.  I also had severe pain in the vaccination arm that I have never experienced before along with two large red spots.
Age: 1.75
Sex: M
Vaccine: FLUN4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child presented at worksite flu clinic for vaccination.  After watching dad receive flumist, parents wanted child to get flumist.  It was not noted until after it had been give that the child was under 2.
Age: 33.0
Sex: M
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Fainted after shot. Blood pressure 78/50. Had water and candy. Felt better after. Stayed with me for ~15 min.  Then left when he felt better
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Difficulty breathing, heart racing
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Hypersomnia, Impaired work ability
Clinical narrative: 9-30 5:00 pm left arm very sore, painful to raise arm up.  10-1-20 at  2:00 am I woke up with a pounding headache.5:00 am still had headache, nauseated, redness to  right side of face (thought it was from sleeping on right side due to left arm painful to lay on).did not take my temp but husband said when he touched my face I felt like I was burning up. Did not go to work felt very tired and slept most of day. took acetaminophen 500mg 2 tabs to relieve headache and left arm pain. did not undress during that day when I went to take shower at 07:30 pm I noticed red rash on front and back of torso and neck. 10-2  9:00 am called doctor to report symptoms and signs.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Rash, Rash erythematous
Clinical narrative: 9-30 5:00 pm left arm very sore, painful to raise arm up.  10-1-20 at  2:00 am I woke up with a pounding headache.5:00 am still had headache, nauseated, redness to  right side of face (thought it was from sleeping on right side due to left arm painful to lay on).did not take my temp but husband said when he touched my face I felt like I was burning up. Did not go to work felt very tired and slept most of day. took acetaminophen 500mg 2 tabs to relieve headache and left arm pain. did not undress during that day when I went to take shower at 07:30 pm I noticed red rash on front and back of torso and neck. 10-2  9:00 am called doctor to report symptoms and signs.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: 9-30 5:00 pm left arm very sore, painful to raise arm up.  10-1-20 at  2:00 am I woke up with a pounding headache.5:00 am still had headache, nauseated, redness to  right side of face (thought it was from sleeping on right side due to left arm painful to lay on).did not take my temp but husband said when he touched my face I felt like I was burning up. Did not go to work felt very tired and slept most of day. took acetaminophen 500mg 2 tabs to relieve headache and left arm pain. did not undress during that day when I went to take shower at 07:30 pm I noticed red rash on front and back of torso and neck. 10-2  9:00 am called doctor to report symptoms and signs.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Pain in extremity, Sleep disorder
Clinical narrative: PATIENT REPORTED PAIN IN ARM, WHICH SHE EXPECTED.  SHE SAID IN THE MIDDLE OF THE NIGHT SHE WOKE UP GASPING FOR BREATH ON 2 OCCASIONS.  SHE REPORTED IT TO HER PHYSICIAN WHO SAID SHE SHOULD TELL US TO REPORT.  SHE SAID SHE ONLY HAD SOB IN THE PAST IF IT'S EXTREMELY HOT IN HER BEDROOM.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: PATIENT RECEIVED FLU SHOT, A FEW MINS LATER FAINTED. WAS RESPONSIVE AFTER A FEW SECONDS AND NORMAL BREATHING. CALLED 911. EMS CAME, CHECKED VITALS. PATIENT WAS GOOD AND ABLE TO LEAVE WITHOUT AMBULANCE.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Flushing, Influenza A virus test negative, Influenza B virus test, Pyrexia
Clinical narrative: within 12 hours, very high fever (105.9), flushing, chills.   Fever >103 lasted 3 days.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: within 12 hours, very high fever (105.9), flushing, chills.   Fever >103 lasted 3 days.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Hyperhidrosis, Pain, Paraesthesia, Skin tightness
Clinical narrative: Patient states that she received vaccines around 4:30pm, afterwards she did feel tingling in her left arm but didn't think much of it.  Around 6:30pm the tingling (tightening of skin feeling, states hard to describe) become more pronounced down left arm, body and leg.  States she went to ER around 8pm for tingling in arm and body, throat closing up and sweats.  States she was there till around 12:30am, they just observed her.  No medication was given per patient.  States she received a prescription for a "steriod" but hadn't taken it yet.  Just took OTC Benadryl when she got home from the hospital.  States a lot of the symptoms resolved just feels exhausted and achy.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Throat tightness
Clinical narrative: Patient states that she received vaccines around 4:30pm, afterwards she did feel tingling in her left arm but didn't think much of it.  Around 6:30pm the tingling (tightening of skin feeling, states hard to describe) become more pronounced down left arm, body and leg.  States she went to ER around 8pm for tingling in arm and body, throat closing up and sweats.  States she was there till around 12:30am, they just observed her.  No medication was given per patient.  States she received a prescription for a "steriod" but hadn't taken it yet.  Just took OTC Benadryl when she got home from the hospital.  States a lot of the symptoms resolved just feels exhausted and achy.
Age: 20.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Onset of a numbess, tingling, and pain to the right lower leg from the knee to the toes, affecting mainly the calf muscle and front portion of the majority of the lower right leg only.  Symptoms begin mildly on the inner calf muscle and during the night of 10/1 into the AM of 10/2 worsened and spread to the entire right lower leg from knee to toe. Currently somewhat lessened by a 400mg OTC dose of Ibuprofen.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received a previous pneumovax 23 vaccine in 2013.  On Wednesday, 9/30/20 patient received a pneumovax 23 vaccine in a syringe at 5:24pm on his right arm.  On Thursday, October 1st, at 8:00am, he noticed redness, swelling and tenderness in his right bicep. He took one over the counter aleve 200mg tablet on 10/1/20 in the morning and at night.  He will contact Dr.'s office.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received Pneumovax on Wednesday 9/30/20 at 5:20PM. On Thursday, Oct 1st 2020 he woke up and noticed redness, swelling and tenderness in his right bicep at 8AM. He took OTC aleve in AM & MS (morning & night) yesterday. He will contact Dr.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Headache, Nausea, Pain
Clinical narrative: Patient stated that he woke up with a headache, no energy, nauseous, body aches, and no fever.