chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis, Herpes virus infection, Rash vesicular
Clinical narrative: Herpes virus infection; Herpesviral vesicular dermatitis; Information has been from a lawyer and a female patient of unknown age regarding a case in litigation on 16-NOV-2019. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or around 13-OCT-2017, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for routine adult health maintenance and for the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered from herpes viral vesicular dermatitis. As a direct and proximate result of the Zoster Vaccine Live (ZOSTAVAX), patient's symptoms had resulted in physical limitations not present prior to vaccination; patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of vaccination with Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a consequence of vaccination, the patient had suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of the events was considered as not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX). The reporter considered herpes viral vesicular dermatitis as disability events.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; 20 year old patient was administrated a pediatric dose of RECOMBIVAX HB; This spontaneous report was received from a Nurse referring to a 20-year-old patient. The patient's concurrent condition, medical history, drug allergies/ reaction and concomitant medications were not reported. On 16-DEC-2019, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, formulation, dose/frequency, route were unknown) lot# N020613, expiry date: 05-MAY-2020 (product administered to patient of inappropriate age) for prophylaxis. No additional adverse effects reported. The outcome of product administered to patient of inappropriate age and no adverse event was unknown.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pruritus, Urticaria
Clinical narrative: Full body hives and itching.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count normal, Laboratory test normal, Pain in extremity, Tachycardia
Clinical narrative: bilateral persistent leg/calf pain the day following immunization, tachycardia, pain improved with tylneol and ibuprofen but required monitoring in the emergency room given severity of pain.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood test normal, Body temperature increased, Chest X-ray normal, Chills
Clinical narrative: On day #1, at 4 PM, I felt chills all over my body, followed shortly thereafter by uncontrollable shaking. My wife put me in bed and covered me with multiple layers of blankets, and the shaking stopped that night. On day #2, I woke with almost complete loss of strength in my legs, such that I could not get out of my chair and could only stand briefly. Later that day, I could not stand at all without assistance. My temperature rose to 101.5. I had no energy and my entire body ached. At 6:30 PM I was taken by Rescue Squad to the emergency room of Hospital. The staff tested my blood and urine and took chest X-rays, all of which were normal. I was released at 9:30 PM, without any new medication and with a diagnosis that the symptoms were likely the result of the vaccination. Back home, I developed new symptoms of excessive gas and diarrhea. On day #3, I woke up with my pajamas drenched with perspiration and with a return to normal body temperature. The gas and diarrhea continued, but strength began to return to my legs. I only wanted to remain sedentary, even though I normally am very active and high energy.  Today is day #4, and the diarrhea is gone, but some abnormal amount of gas remains. I am able to walk down the driveway  to the mailbox.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Dysstasia, Flatulence, Gait inability, Pain
Clinical narrative: On day #1, at 4 PM, I felt chills all over my body, followed shortly thereafter by uncontrollable shaking. My wife put me in bed and covered me with multiple layers of blankets, and the shaking stopped that night. On day #2, I woke with almost complete loss of strength in my legs, such that I could not get out of my chair and could only stand briefly. Later that day, I could not stand at all without assistance. My temperature rose to 101.5. I had no energy and my entire body ached. At 6:30 PM I was taken by Rescue Squad to the emergency room of Hospital. The staff tested my blood and urine and took chest X-rays, all of which were normal. I was released at 9:30 PM, without any new medication and with a diagnosis that the symptoms were likely the result of the vaccination. Back home, I developed new symptoms of excessive gas and diarrhea. On day #3, I woke up with my pajamas drenched with perspiration and with a return to normal body temperature. The gas and diarrhea continued, but strength began to return to my legs. I only wanted to remain sedentary, even though I normally am very active and high energy.  Today is day #4, and the diarrhea is gone, but some abnormal amount of gas remains. I am able to walk down the driveway  to the mailbox.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor, Urine analysis normal
Clinical narrative: On day #1, at 4 PM, I felt chills all over my body, followed shortly thereafter by uncontrollable shaking. My wife put me in bed and covered me with multiple layers of blankets, and the shaking stopped that night. On day #2, I woke with almost complete loss of strength in my legs, such that I could not get out of my chair and could only stand briefly. Later that day, I could not stand at all without assistance. My temperature rose to 101.5. I had no energy and my entire body ached. At 6:30 PM I was taken by Rescue Squad to the emergency room of Hospital. The staff tested my blood and urine and took chest X-rays, all of which were normal. I was released at 9:30 PM, without any new medication and with a diagnosis that the symptoms were likely the result of the vaccination. Back home, I developed new symptoms of excessive gas and diarrhea. On day #3, I woke up with my pajamas drenched with perspiration and with a return to normal body temperature. The gas and diarrhea continued, but strength began to return to my legs. I only wanted to remain sedentary, even though I normally am very active and high energy.  Today is day #4, and the diarrhea is gone, but some abnormal amount of gas remains. I am able to walk down the driveway  to the mailbox.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Fatigue, Headache, Pain
Clinical narrative: See email form patient: Hi. I had the 1st part shingles Zoster vaccine last Thursday morning, December1 19th. By late afternoon I was feverish, had chills, aches and pains, headache, felt off balance , which lasted for a few days. By Sunday I just felt tired, a little off balance at times, and slightly achey. I read the handout on the vaccine I was given and it said this may happen in a small percentage of people. Online I read that the CDC recommends the Shringrix over the Zoster because it's more effective. I'm wondering about this. I felt I should report to you my reaction from this vaccine. Hopefully today will be a healthier feeling day. I very rarely catch any viruses or feel badly. Happy holiday to you.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: See email form patient: Hi. I had the 1st part shingles Zoster vaccine last Thursday morning, December1 19th. By late afternoon I was feverish, had chills, aches and pains, headache, felt off balance , which lasted for a few days. By Sunday I just felt tired, a little off balance at times, and slightly achey. I read the handout on the vaccine I was given and it said this may happen in a small percentage of people. Online I read that the CDC recommends the Shringrix over the Zoster because it's more effective. I'm wondering about this. I felt I should report to you my reaction from this vaccine. Hopefully today will be a healthier feeling day. I very rarely catch any viruses or feel badly. Happy holiday to you.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Lethargy
Clinical narrative: Shaking chills, Lethargy, Acute fatigue, Diarrhea, Loss of appetite, probable fever for 5 to 7 days
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Pyrexia, Tremor
Clinical narrative: Shaking chills, Lethargy, Acute fatigue, Diarrhea, Loss of appetite, probable fever for 5 to 7 days
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Violent vomiting for 18 hours
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Patient woke up at midnight, and started vomiting everywhere. No fever or other symptoms. Lasted for a couple minutes with intermittent vomiting, then she was fine.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Severe shivering/chills, sweats, muscle pain, joint pain, headache, fatigue, severe thirst. Tylenol and Advil ,Chicken soup, water and Gatorade.. Feel okay 3rd day out, but still very thirsty. Doctor failed to warn/discuss severe adverse side effects at time of vaccination. Had I been informed, I would not have been vaccinated.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Thirst
Clinical narrative: Severe shivering/chills, sweats, muscle pain, joint pain, headache, fatigue, severe thirst. Tylenol and Advil ,Chicken soup, water and Gatorade.. Feel okay 3rd day out, but still very thirsty. Doctor failed to warn/discuss severe adverse side effects at time of vaccination. Had I been informed, I would not have been vaccinated.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: None stated.
Age: 33.0
Sex: M
Vaccine: ANTH, MMR, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: C/O redness, warmth, pain at injection site right arm. Seen by provider Dec 8, 2019. Antibiotics ordered. Care sought within 48 hrs.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse effects reported; One female patient was administered a dose of properly stored VARIVAX intramuscularly instead of subcutaneously; Information has been received from a physician regarding a 13-months-old female patient. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 16-DEC-2019, the patient was vaccinated with a dose of properly stored varicella virus vaccine live (oka/merck) (VARIVAX) intramuscular injection as prophylaxis (lot number S024964 with expiration date in 06-AUG-2021) which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (strength and anatomical location not reported) (incorrect route of product administration).  No additional adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: she read an article regarding a study showing a correlation between patients vaccinated with GARDASIL 9 and infertility; This spontaneous report was received from a physician via company representative, referring to an unspecified patients of unknown age and gender. Information about patients pertinent concurrent conditions, medical history, concomitant medication, previous drug reactions or allergies were unknown by the reporter.  On an unknown date, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported, lot number and expiration date were unknown by the reporter).  The reporter stated, that "she read an article, regarding a study that showed a correlation between patients vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9 and infertility". It was unknown by the reporter, if any of the patients sought medical attention, if any treatment was given to the patients or if laboratories diagnostic or studies were performed.   At time of this report, the outcome of infertility was not reported.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event of infertility was not reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; A toddler patient was administered a dose of improperly stored VARIVAX; Information has been received from a nurse regarding a 12-months-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 19-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection as prophylaxis (lot number S021924 with expiration date in 15-JUL-2021) which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot number: R032162 with expiration date: 22-JUL-2021) (route of administration, strength and anatomical location not reported) (incorrect product storage).  The varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F (24.3 F) for multiple time frames. There was no previous temperature excursion and the call was because of a data logger.  No adverse effects reported.
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria, Rash, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: injection site (arm) has a spot about 3 inches and there is also a 1 x 2 inch patch; The rash on her face was more like on the side of her neck; bunch of little hives around the injection site, almost like where it spread; she can feel heat; It is sometimes itchy; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 32 years old female patient who experienced injection site (arm) has a spot about 3 inches and there is also a 1 x 2 inch patch (vaccination site reaction), rash on her face was more like on the side of her neck (rash), bunch of little hives around the injection site, almost like where it spread (urticaria), she can feel heat (vaccination site warmth) and it is sometimes itchy (vaccination site pruritus), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination(s) included INFLUENZA VACCINE.  Medical history, medical treatment(s) and family history were not provided.   On 09-Nov-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UJ279AA and expiry date: 06-Jun-2019) via unknown route in the right arm.  On an unknown date, the patient experienced a non-serious injection site (arm) has a spot about 3 inches and there is also a 1 x 2 inch patch (vaccination site reaction) (Unknown latency), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that, another wheal that is raised. There was also a 1 x 2 inch patch and under that, an inch circle on her arm. Her face was red. The mom of the patient told the pharmacist that the reaction was a little better than at first. It still seems to have heat in it. It was reported that, the rash on her face was more like on the side of her neck and is gone now(rash). The rash on her arm is still there but not getting bigger. It is sometimes itchy (vaccination site pruritus) and she can feel heat (vaccination site warmth). It was reported that, it looks like a bunch of little hives around the injection site, almost like where it spread (urticaria).  No laboratory data reported.  Final diagnosis was vaccination site pruritus, vaccination site warmth, rash, urticarial and vaccination site reaction.   It was not reported if the patient received a corrective treatment.  On an unknown date, the patient outcome were reported as recovering for vaccination site reaction and rash.  The patient outcome were reported as unknown for urticarial, vaccination site warmth and vaccination site pruritus.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 5 months and 22 days old female patient received a dose of Fluzone Quadrivalent/No AE; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to case 2019SA320134.  This case involves a five months and 22 days old female patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6656NA, expiry date: 30-Jun-2020 via intramuscular route in the right thigh On an unknown date.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was an actual medication error due to inappropriate age at vaccine administration.  No side effect were noted.  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.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Musculoskeletal disorder, Ocular hyperaemia, Pain in extremity, Peripheral swelling
Clinical narrative: arm was swollen and red and that hurt; she cannot use her arm; eyes became blood shot; high fever; Initial information received on 13-Dec-2019 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 65 years old female patient who experienced swollen and red arm and that hurt ((inflammation), eyes became blood shot (ocular hyperaemia), high fever (pyrexia) and she cannot use her arm (mobility decreased), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Dec-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ307AA expiry date: 29-Jun-2020 via unknown route in the right deltoid.  On 11-Dec-2019, the patient developed a non-serious swollen and red arm, that hurt (inflammation), eyes became blood shot (ocular hyperaemia), high fever (pyrexia) and she cannot use her arm (mobility decreased) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Laboratory details were not reported.  Final diagnosis was inflammation, ocular hyperaemia pyrexia and mobility decreased.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for inflammation, ocular hyperaemia pyrexia and mobility decreased.
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: arm was swollen and red and that hurt; she cannot use her arm; eyes became blood shot; high fever; Initial information received on 13-Dec-2019 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 65 years old female patient who experienced swollen and red arm and that hurt ((inflammation), eyes became blood shot (ocular hyperaemia), high fever (pyrexia) and she cannot use her arm (mobility decreased), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Dec-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ307AA expiry date: 29-Jun-2020 via unknown route in the right deltoid.  On 11-Dec-2019, the patient developed a non-serious swollen and red arm, that hurt (inflammation), eyes became blood shot (ocular hyperaemia), high fever (pyrexia) and she cannot use her arm (mobility decreased) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Laboratory details were not reported.  Final diagnosis was inflammation, ocular hyperaemia pyrexia and mobility decreased.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for inflammation, ocular hyperaemia pyrexia and mobility decreased.
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth, Ocular hyperaemia
Clinical narrative: eyes are blood shoot red; feel bad; high fever; right arm was swollen, red an feverish at the injection site; swollen at the injection site; red at the injection site; feverish at the injection site; Initial information was received on 13-Dec-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 65 year old female patient who reported that her eyes are blood shoot red (ocular hyperaemia), she feel bad (feeling abnormal), had high fever and right arm  was swollen, was red and feverish at the injection site (vaccination site inflammation), (vaccination site swelling), (vaccination site erythema) and (vaccination site warmth), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination included influenza vaccine with sickness and flu. Medical history, medical treatment and family history were not provided.  On 11-Dec (year unknown), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the right arm.  On an unknown date, the patient developed a non-serious feel bad (feeling abnormal) 2 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed a non-serious eyes are blood shoot red (ocular hyperaemia), high fever (pyrexia), right arm was swollen, red and feverish at the injection site (vaccination site inflammation), (vaccination site swelling), (vaccination site erythema) and (vaccination site warmth) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no laboratory data.)  Final diagnosis was right arm was swollen, red and feverish at the injection site, high fever, feel bad and eyes are blood shoot red.  The patient was treated with Paracetamol (Tylenol).  The patient was not recovered from ocular hyperaemia and outcome of other events were unknown.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: eyes are blood shoot red; feel bad; high fever; right arm was swollen, red an feverish at the injection site; swollen at the injection site; red at the injection site; feverish at the injection site; Initial information was received on 13-Dec-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 65 year old female patient who reported that her eyes are blood shoot red (ocular hyperaemia), she feel bad (feeling abnormal), had high fever and right arm  was swollen, was red and feverish at the injection site (vaccination site inflammation), (vaccination site swelling), (vaccination site erythema) and (vaccination site warmth), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination included influenza vaccine with sickness and flu. Medical history, medical treatment and family history were not provided.  On 11-Dec (year unknown), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the right arm.  On an unknown date, the patient developed a non-serious feel bad (feeling abnormal) 2 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed a non-serious eyes are blood shoot red (ocular hyperaemia), high fever (pyrexia), right arm was swollen, red and feverish at the injection site (vaccination site inflammation), (vaccination site swelling), (vaccination site erythema) and (vaccination site warmth) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no laboratory data.)  Final diagnosis was right arm was swollen, red and feverish at the injection site, high fever, feel bad and eyes are blood shoot red.  The patient was treated with Paracetamol (Tylenol).  The patient was not recovered from ocular hyperaemia and outcome of other events were unknown.  Information on the batch number was requested.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: expired dose of Fluzone Quadrivalent administered; Initial information received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 13 months old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that expired dose of Fluzone Quadrivalent administered (expired vaccine administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 11-Nov-2019, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On 16-Dec-2019 she also received a second dose (0.25 ml) of the same vaccine lot UP6259LA and expiry date: 30-Jun-2019 via intramuscular route in the right thigh.  It was a case of actual medication error due to expired vaccine used.  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.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia, Influenza like illness, Peripheral swelling, Swelling face
Clinical narrative: 12/2 got vaccine 12 noon by 5 pm pt felt like had the flu (achy) at 8pm face swelling & numbness took benadryl 25g. Arm is swollen and red as of 12/5
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: FEVER, CHILLS NAUSEA
Sex: U
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Differential white blood cell count normal, Full blood count normal, Pyrexia
Clinical narrative: Fever up to 104.3'F 24-hours after vaccination. Fever lasted for 12 hours
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: Developed diarrhea after receiving vaccines.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Trigger finger
Clinical narrative: I THINK IT WAS A REATION OF A TRIGER FINGER NOT THE VACCINE
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Decreased appetite, Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: day after vaccination, patient had swelling of Left thigh and local erythema surrounding vaccine sight. tender to touch, fever. Mother applied ice regularly. Patient with low appetite, diarrhea, 3 plus fussiness. 3 days after vaccine, thigh swelling and erythema significantly improved
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site warmth, Irritability
Clinical narrative: day after vaccination, patient had swelling of Left thigh and local erythema surrounding vaccine sight. tender to touch, fever. Mother applied ice regularly. Patient with low appetite, diarrhea, 3 plus fussiness. 3 days after vaccine, thigh swelling and erythema significantly improved
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Decreased appetite, Henoch-Schonlein purpura, Injection site bruising, Injection site erythema
Clinical narrative: Injection site was raised and irritated the day following injection (12/13) with worsening 2 days after receiving the shot. On 12/14, I noticed the area was raised, red, itchy, and bruised. The affected area around the injection site was about 2-2.5? in diameter. I applied hydrocortisone cream and applied ice to the area.  The area did go down, but on 12/19 she woke up with hive-like spots on her back and torso and had congestion. I gave her a decongestant before I realized she had hives. The rash became more red and itchy, and eventually made its way to her face. Zyrtec given at 12:00 with further evaluation from her pediatrician later that afternoon. Benadryl given at 12:00 midnight and again at 6 AM with no relief. The next day the rash had tripled in size and covered the majority of her trunk, limbs, and almost all of her face. Decreased appetite and fever now accompanied the rash. She was taken to the ER after I noticed she was biting her lips and was experiencing facial swelling. The initial injection site was also raised and itchy outside of the area that was first affected. ER gave her a dose of oral prednisone, Benadryl, and Motrin to combat fever. Antibiotic was switched to Zithromax and we were discharged. The next day there was no improvement. The areas of skin first affected by the rash were now darkening and turning more purple, but newer areas were pink. She was taken back to her pediatrician where she was evaluated. Her pediatrician advised we take her to the emergency room to be treated for HSP. ER physician suspected serum sickness. She was treated with IV fluids, IV steroids, hydroxyzine.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Injection site irritation, Injection site pruritus, Injection site swelling, Oral discomfort, Pyrexia
Clinical narrative: Injection site was raised and irritated the day following injection (12/13) with worsening 2 days after receiving the shot. On 12/14, I noticed the area was raised, red, itchy, and bruised. The affected area around the injection site was about 2-2.5? in diameter. I applied hydrocortisone cream and applied ice to the area.  The area did go down, but on 12/19 she woke up with hive-like spots on her back and torso and had congestion. I gave her a decongestant before I realized she had hives. The rash became more red and itchy, and eventually made its way to her face. Zyrtec given at 12:00 with further evaluation from her pediatrician later that afternoon. Benadryl given at 12:00 midnight and again at 6 AM with no relief. The next day the rash had tripled in size and covered the majority of her trunk, limbs, and almost all of her face. Decreased appetite and fever now accompanied the rash. She was taken to the ER after I noticed she was biting her lips and was experiencing facial swelling. The initial injection site was also raised and itchy outside of the area that was first affected. ER gave her a dose of oral prednisone, Benadryl, and Motrin to combat fever. Antibiotic was switched to Zithromax and we were discharged. The next day there was no improvement. The areas of skin first affected by the rash were now darkening and turning more purple, but newer areas were pink. She was taken back to her pediatrician where she was evaluated. Her pediatrician advised we take her to the emergency room to be treated for HSP. ER physician suspected serum sickness. She was treated with IV fluids, IV steroids, hydroxyzine.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Rash erythematous, Rash pruritic, Respiratory tract congestion, Serum sickness
Clinical narrative: Injection site was raised and irritated the day following injection (12/13) with worsening 2 days after receiving the shot. On 12/14, I noticed the area was raised, red, itchy, and bruised. The affected area around the injection site was about 2-2.5? in diameter. I applied hydrocortisone cream and applied ice to the area.  The area did go down, but on 12/19 she woke up with hive-like spots on her back and torso and had congestion. I gave her a decongestant before I realized she had hives. The rash became more red and itchy, and eventually made its way to her face. Zyrtec given at 12:00 with further evaluation from her pediatrician later that afternoon. Benadryl given at 12:00 midnight and again at 6 AM with no relief. The next day the rash had tripled in size and covered the majority of her trunk, limbs, and almost all of her face. Decreased appetite and fever now accompanied the rash. She was taken to the ER after I noticed she was biting her lips and was experiencing facial swelling. The initial injection site was also raised and itchy outside of the area that was first affected. ER gave her a dose of oral prednisone, Benadryl, and Motrin to combat fever. Antibiotic was switched to Zithromax and we were discharged. The next day there was no improvement. The areas of skin first affected by the rash were now darkening and turning more purple, but newer areas were pink. She was taken back to her pediatrician where she was evaluated. Her pediatrician advised we take her to the emergency room to be treated for HSP. ER physician suspected serum sickness. She was treated with IV fluids, IV steroids, hydroxyzine.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Skin discolouration, Swelling face, Urticaria
Clinical narrative: Injection site was raised and irritated the day following injection (12/13) with worsening 2 days after receiving the shot. On 12/14, I noticed the area was raised, red, itchy, and bruised. The affected area around the injection site was about 2-2.5? in diameter. I applied hydrocortisone cream and applied ice to the area.  The area did go down, but on 12/19 she woke up with hive-like spots on her back and torso and had congestion. I gave her a decongestant before I realized she had hives. The rash became more red and itchy, and eventually made its way to her face. Zyrtec given at 12:00 with further evaluation from her pediatrician later that afternoon. Benadryl given at 12:00 midnight and again at 6 AM with no relief. The next day the rash had tripled in size and covered the majority of her trunk, limbs, and almost all of her face. Decreased appetite and fever now accompanied the rash. She was taken to the ER after I noticed she was biting her lips and was experiencing facial swelling. The initial injection site was also raised and itchy outside of the area that was first affected. ER gave her a dose of oral prednisone, Benadryl, and Motrin to combat fever. Antibiotic was switched to Zithromax and we were discharged. The next day there was no improvement. The areas of skin first affected by the rash were now darkening and turning more purple, but newer areas were pink. She was taken back to her pediatrician where she was evaluated. Her pediatrician advised we take her to the emergency room to be treated for HSP. ER physician suspected serum sickness. She was treated with IV fluids, IV steroids, hydroxyzine.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event reported, but patient received a third dose of vaccine
Age: 61.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: RASH AND ITCHING STARTED SHORTLY AFTER RECEIVING VACCINES. RASH ON ARMS AND LEGS. INSTRUCTED BY APRN TO TAKE BENADRYL EVERY 4-6 HOURS ORALLY. USE CALAMINE LOTION TO SOOTH SKIN. WILL FOLLOW-UP WITH CLIENT IN A FEW DAYS.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient reported arm pain ever since the date of the injection (it has lasted for one and a half months now). He will make an appointment to see his doctor in the coming weeks.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Dtap/IPV and MMRV was given on 12/23/19 and it was later discovered that the patient had already had these vaccines on 12/05/18.   These 2 vaccines were given when they should not  have been given.  There were no adverse effects or complaints from the patient per the  patient's mother.  The patient was not running a fever and was continuing to play without any problems per patient's mother.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Head injury, Loss of consciousness
Clinical narrative: pt said she passed out as she was getting home, within 5 to 10 minutes of receiving the vaccine.  She hit her head and ended up going to the emergency room.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: swelling of entire L arm, persistent 4 days after vaccine
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: PT SAID SHE HAD A BIT OF SORENESS AT SITE. SHE APPROXIMATELY 2 DAYS LATER GOT THE SHINGLES. WENT TO URGENT CARE TODAY AND WAS GIVEN VALTREX AND PREDNISONE
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt received flu shot on 10-9-19. Reported sore arm as of 12-22-19
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema, Peripheral swelling, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Patient states that she was told by pharmacy to be seen by doctor due to having a possible allergic reaction to shingrix 2nd dose.  Patient states that on Saturday 12/21/2019 she started having a rash under her left upper arm that was puritic in nature.  She states it then started under her right upper arm that was then followed by swelling in both arms and hands and both feet.  Patient had macular erythematous puritic rash to bilateral upper arms and 1+ pitting edema to bilateral feet.  Non-pitting edema to  bilateral hands, arms and chin.  Patient was prescribed Medrol dose pack for 6 days for this reaction.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient says her arm is still sore today that she can barely raise her arm and that she can still see injection site spot.  She says she started icing it about 3 days after getting the shot.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient called saying he had been experiencing a lot of swelling, redness and pain.  Patient said he did ice for a week on and off. He spoke to his dr office and they are sending him for an ultrasound
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: high fever, extreme redness at injection site, a lot of swelling at injection site on next day (Sat) after injection; pt had to go to hospital due to pain and fever; pt was given ibuprofen and had been applying ice; symptoms have improved a bit by Monday
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Erythema, Feeling hot, Insomnia, Pain in extremity
Clinical narrative: On 11/21/19 patient experienced redness, pain, and hot sensation in the arm where the injection occurred. She could not sleep due to the severity of pain and came to the pharmacy for advise. We advised her it was a possible side effect after the vaccine and to try to put ice on the painful area. She continued to use ice for 3 weeks and the redness got better but she still experiences pain in the arm. On 12/19/19 she noticed the arm is now showing a bruise and she still had the pain. She describes it as a shooting pain in her am that happens all the time. The pharmacy referred her to her primary physician.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Acute flaccid myelitis, Immunoglobulin therapy, Magnetic resonance imaging spinal abnormal, Muscular weakness
Clinical narrative: Patient with Acute-flaccid myelitis. Patient presented with bilateral lower extremity weakness, truncal weakness, & upper extremity weakness, 3 days IVIG 2 g/kg 3 3 day 5 g/day steroids
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Heart rate increased, Tachycardia
Clinical narrative: Tachycardia at seconds after receiving influenza vaccine, patient's heart rate became very rapid went up to 1600's to 1800's. BP was lower 90/60 from 110/70 but he was asymptomatic. Provider was notified
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Tachycardia
Clinical narrative: Tachycardia resolved as patient was monitored ~20 minutes after influenza vaccine administration
Age: 74.0
Sex: M
Vaccine: DT
Symptoms: Altered state of consciousness, Dizziness, Nausea
Clinical narrative: Dizziness & nausea, almost passed out
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: & CELLULITIS
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema multiforme, Malignant melanoma, Pruritus, Swelling, Urticaria
Clinical narrative: ErythemaMultiform, UrticariaPruritus & swelling, melanoma  DIPHENHYDRAMINE 50 MG QID ,PREDNISONE 50 MG EVERY DAY ,CLINDAMYCIN 300 MG QID
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash, UrticariaPruritus & URTICARIA
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Nausea, Vomiting
Clinical narrative: Symptoms:   NauseaVomiting & VOMITING
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Fever of 100 and red rash that was 5 inches below injection site
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; a male Patient received improperly stored VAQTA; vaccine expiration date: 05-MAY-2019; This spontaneous report has been received from a medical assistant referring to a 20 months old male patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 14-NOV-2019, the patient was vaccinated with impeoperly stored hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (unit unknown) (lot # S009562, expiration date reported as 26-JUL-2020 but upon internal validation established as 05-MAY-2019; route, frequency and dose details were unknown) for prophylaxis (product storage error and expired product administered).   The vaccine was stored above 47 degrees Fahrenheit (52.09 degrees Fahrenheit) for 1.39 hours. The previous temperature excursion included above 47 degrees Fahrenheit (64.83 degrees Fahrenheit) for 13.35 hours. The digital data logger was involved. No additional adverse effect reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; a patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant medication and drug reactions/allergies were not provided.     On 13-DEC-2019, the patient was administered a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength and dose were not provided; lot# reported as S020158, expiration date reported as 30-JUN-2021) by subcutaneous route for prophylaxis. The sterile diluent used for administration was properly stored. The temperature excursions included -11.4 Celsius degree for 8 hours and 15 minutes. Temperature previously excursion was -11.7 Celsius degree for 4 hours and 3 minutes. There was a data logger involved. The patient experienced no symptoms.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: missed dose; he still had not gotten the third dose of GARDASIL 9; No adverse event information was provided; This spontaneous report has been received from a 45-year-old male dentist (also reported as physician (conflicting information) reporting about himself.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On an unspecified date, the patient was administered the first two doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis.  It was reported that on an unspecified date (reported as on schedule at 6th month), when the patient went to get his third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), the insurance denied coverage of the third dose at the time, which resulted in a missed dose. It was reported that it was now 8 and a half month since the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and he still had not gotten the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of vaccine administered. No adverse event information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Facial paralysis, Pyoderma gangrenosum
Clinical narrative: Bell's Palsy; Pyoderma Gangrenosum; Information has been received from lawyers referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or around 31-OCT-2014, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and the prevention of shingles (herpes zoster).    On an unknown date, the patient experienced suffered a sudden drooping of the left side of his face as well as numbness in left side of his mouth resulting in diagnosis of Bell's Palsy. The patient also suffered reoccurring blisters of both his hands and was diagnosed with Pyoderma Gangrenosum. The patient did not recover from the events. As per the reporter, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were disabling.  The reporter considered the events were related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events were determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product use in unapproved indication
Clinical narrative: drug used for unaproved indication; no adverse event; This spontaneous report was received from a pharmacist regarding a female patient of unknown age. The patient's medical history and concomitant medications were not reported. Current condition included alpha-1 anti-trypsin abnormal. Yearly on unspecified date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, frequency, route, lot # and expiry date were not reported) for alpha-1 anti-trypsin disease (product use in unapproved indication). It was reported that while on the call, pharmacist asked the patient, who was at the pharmacy, if she would like to complete safety report but the patient refused. No additional adverse event reported.