chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 01-OCT-2018 the patient was administered an improperly stored dose of PROQUAD therapy type: recombinant Human albumin (rHA) (lot # N023968 and expiration date 28-FEB-2019, route, strength and frequency were not reported) with properly stored Merck Sterile Diluent for prophylaxis. The vaccine was exposed to temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 9 days and -9 degrees Celsius to 8 degrees Celsius for 3 days. There were no previous excursions reported. The call was not because of a data logger. No adverse effect was reported. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1810USA004588; US-009507513-1810USA006947.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Fatigue, Feeling abnormal, Headache, Lethargy, Pain in extremity
Clinical narrative: Patient states that with vomiting the day after vaccines, as well with a fever, feeling lethargic. 10/23/18 02:53PM Patient presents with dad with complaint of "low grade fever, fatigue, HAs, and vomiting" x 6 hours. Patient states he was at school this morning when he started feeling bad. Patient states he went to the school nurse who said he had a "low grade temp" and administered a dose of TYLENOL. Patient states he also vomited once this morning- no blood in emesis. No emesis in the last 3 hours. Patient states he feels tired and had a HA earlier. Patient states his head hurt "on his forehead," but it seems to be better now with the TYLENOL administration. Patient was seen in office yesterday for his WCC where he received the flu, MenB, and MCV4 vaccines. Patient states his arms are a little sore, but he denies any redness or swelling to the administration sites. Patient denies congestion, cough, ear pain, sore throat, ABD pain, diarrhea, or rash. Patient is eating and drinking well. No sick contacts.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient states that with vomiting the day after vaccines, as well with a fever, feeling lethargic. 10/23/18 02:53PM Patient presents with dad with complaint of "low grade fever, fatigue, HAs, and vomiting" x 6 hours. Patient states he was at school this morning when he started feeling bad. Patient states he went to the school nurse who said he had a "low grade temp" and administered a dose of TYLENOL. Patient states he also vomited once this morning- no blood in emesis. No emesis in the last 3 hours. Patient states he feels tired and had a HA earlier. Patient states his head hurt "on his forehead," but it seems to be better now with the TYLENOL administration. Patient was seen in office yesterday for his WCC where he received the flu, MenB, and MCV4 vaccines. Patient states his arms are a little sore, but he denies any redness or swelling to the administration sites. Patient denies congestion, cough, ear pain, sore throat, ABD pain, diarrhea, or rash. Patient is eating and drinking well. No sick contacts.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Lacrimation increased, Pyrexia
Clinical narrative: Woke up with runny eyes, fever, swollen and hot arm at injection site.
Age: 1.08
Sex: M
Vaccine: FLU4, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Approximately 5-10 minutes after completing administration of immunization patient right thigh (especially area where varicella was administered) became red, swollen and warm to the touch. Hives were present, patient was examined by a provided and BENADRYL was order and administered. Patient was observed by office for approximately 40 more minutes and parents left home with instructions.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Arm pain, mostly in shoulder, when raising it or lifting things. Started immediately after shot, and has increased in intensity over 3 weeks. Injection was very high up on arm.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: Lump, warm and 2 red spots on arm, referred to MD.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: 10/22 - experienced headache, backache, and overall fatigue. 10/23 - worsening of headache, backache, and overall fatigue during the day; in the evening, patient had chills, sweating, tremors, and fever; took 3 tablets of ibupropfen 200 mg and fever decreased from 100.8 to 99 after 4 hours; took an additional dose of ibuprofen at bedtime. 10/24 - pt now reports feeling well and no other issues.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: 10/22 - experienced headache, backache, and overall fatigue. 10/23 - worsening of headache, backache, and overall fatigue during the day; in the evening, patient had chills, sweating, tremors, and fever; took 3 tablets of ibupropfen 200 mg and fever decreased from 100.8 to 99 after 4 hours; took an additional dose of ibuprofen at bedtime. 10/24 - pt now reports feeling well and no other issues.
Age: 54.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Haemorrhage, Purulent discharge, Rash, Rash pruritic, Rash pustular
Clinical narrative: Patient said the rash didn't start right away, maybe a week later. A few pustules broke out in the beginning and advanced to several more down her left arm. They had pus, swelled, and bled. She said they were itchy and warm. OTC Benadryl cream did not help, so she saw Dr today (10-24-18). He prescribed Prednisone 20mg (1 bid for 5 days, then 1 tablet daily for 5 days) and Minocycline 100mg 1 capsule daily for 10 days.
Age: 54.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Patient said the rash didn't start right away, maybe a week later. A few pustules broke out in the beginning and advanced to several more down her left arm. They had pus, swelled, and bled. She said they were itchy and warm. OTC Benadryl cream did not help, so she saw Dr today (10-24-18). He prescribed Prednisone 20mg (1 bid for 5 days, then 1 tablet daily for 5 days) and Minocycline 100mg 1 capsule daily for 10 days.
Age: 14.0
Sex: M
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Patient received the PREVNAR 13 vaccine instead of HPV vaccine.
Age: 88.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness
Clinical narrative: Stomach upset, diarrhea, dizziness.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Myalgia, Neck pain, Neuralgia, Pain in extremity
Clinical narrative: "Felt nerve pain after. Pain into neck, supraspinatus muscle, down lateral arm, into thumb and first two fingers of right hand; across back below scapula felt muscle weakness and shoulder instability of right shoulder and scapula. Burning nerve pain also along scapula on spinal side." Pain description check boxes include: ache, burning, numbness, pins/needles, stabbing.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: "Felt nerve pain after. Pain into neck, supraspinatus muscle, down lateral arm, into thumb and first two fingers of right hand; across back below scapula felt muscle weakness and shoulder instability of right shoulder and scapula. Burning nerve pain also along scapula on spinal side." Pain description check boxes include: ache, burning, numbness, pins/needles, stabbing.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Neck stiffness, myalgia - started 1 hour after receiving flu vaccine on 10/23/18, persists when seen on 10/24/18 at 1440.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Patient reported increased swelling and redness that was spreading on the arm. Went to MD, given antibiotic for cellulitis. Patient also reports having a fever.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Cough
Clinical narrative: Patient received high dose flu shot on 10/20/18 at 2:43pm and states that she started experiencing a severe cough during that nighttime on the same day. As a result patient took a dose of ZYRTEC that night and the next night which help alleviate the cough. Patient states she still has minor cough as of 10/23/18. Patient has gotton flu shot in the past with no reaction.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, C-reactive protein, Contusion, Dizziness, Electrocardiogram
Clinical narrative: Racing heart, headache, dizziness, near syncope, nauseated, weakness, irregular heart rhythm, redness around the injection site, large lump around the site, immediate bruising, blotchy (spider web looking) redness in arms and legs.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Headache, Heart rate irregular, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Racing heart, headache, dizziness, near syncope, nauseated, weakness, irregular heart rhythm, redness around the injection site, large lump around the site, immediate bruising, blotchy (spider web looking) redness in arms and legs.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Nausea, Palpitations, Presyncope, Rash macular
Clinical narrative: Racing heart, headache, dizziness, near syncope, nauseated, weakness, irregular heart rhythm, redness around the injection site, large lump around the site, immediate bruising, blotchy (spider web looking) redness in arms and legs.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm pain with restricted range of motion. Immediate onset, worsened over 3 days and then improved. Still slightly symptomatic.
Age: 55.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Cheilitis, Lip swelling
Clinical narrative: PT WAS ADMINISTERED SHINGHRIX (2ND DOSE) AND PT CAME TO PHARMACY AFTER FEW DAYS STATING THAT HE HAD RASH ON HIS LIPS AND SWELLING IN THE LIPS, PT WAS ADVISED TO CONSULT HIS PRIMARY CARE MD: PT WAS CONSULTED WITH DR AND AS PER MD PT HAD A MINOR REACTION TO THE VACCINATION AND PT WAS FINE AND HIS RASH STARTED GOING AWAY AND SWELLING WAS GONE.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash generalised
Clinical narrative: Patient received flu vaccine on 10/20/18 at 2:43pm and states she experienced whole body rash during the same day in the evening around 7pm. Patient states there was no itching and she's received the flu shot before with no known reaction. Patient took ZYRTEC to help with the rash, but states it did not help and each day since the shot the rash gets worse. Patient states the rash is 5mm-10mm in measurement. Patient has been taking ZYRTEC in the morning and BENADRYL at night since the event. Pharmacist recommended patient see a doctor since antihistamine was not providing any relief and patient mentioned rash keeps getting worse.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Antinuclear antibody, Blood immunoglobulin E, C-reactive protein, Culture urine, Full blood count
Clinical narrative: Next day after the vaccine dose administration she begans with itching and skin rash in the left arm. Urticaria all over the body with persistent  skin rash. She went to the primary physician office to be evaluated on october 11, 2018.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Lipids, Metabolic function test, Pruritus, Rash, Rheumatoid factor
Clinical narrative: Next day after the vaccine dose administration she begans with itching and skin rash in the left arm. Urticaria all over the body with persistent  skin rash. She went to the primary physician office to be evaluated on october 11, 2018.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Thyroxine free, Urine analysis, Urticaria, Vitamin D
Clinical narrative: Next day after the vaccine dose administration she begans with itching and skin rash in the left arm. Urticaria all over the body with persistent  skin rash. She went to the primary physician office to be evaluated on october 11, 2018.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Rash erythematous, Skin warm, Tenderness
Clinical narrative: Rash-red, raised, warm and tender to touch. Assessed as cellulitis. Prescribed KEFLEX 500 mg capsules (40).
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: MSK pain surrounding injection site rated 7/10 since administration of vaccine. Had not subsided and still persisting x 1 month after vaccine injection.
Age: 55.0
Sex: F
Vaccine: FLUR4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Reports severe pain in arm and decreased ROM in arm beginning the day of vaccine.
Age: 63.0
Sex: U
Vaccine: FLUC4
Symptoms: Pruritus, Rash
Clinical narrative: Patient was fine when she left the pharmacy. When she woke up in the morning she was itching under both arm pits and then noticed she had a rash under both breasts and upper back. She took a benadryl 25mg and the symptoms went away.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: Itching and swelling of both eyes starting at 11:45.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Patient received FLUZONE HIGH DOSE 2018-19 vaccine on 10/17/18. Over the following weekend 10/20-21/18 she developed a rash/hives. She received medication to treat the reaction and reported the reaction on 10/24/18.
Age: 74.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Vaccination site warmth
Clinical narrative: Patient received the vaccine by a pharmacist on 10/10/18. Patient was then seen at Clinic by her primary care provider on 10/12/18,  complaining of itchiness, warmth, and redness at the vaccine site. The physician determined that the vaccine was given in the biceps instead of the deltoid, and diagnosed the patient with cellulitis due to vaccine administration. The patient was given a 7 day course of cephalexin 500 mg, 1 capsule three times daily, and symptoms have resolved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Limb mass, Mobility decreased, Pain in extremity
Clinical narrative: Patient called pharmacist on Saturday October 6th. Patient developed "triangle" rash around the area of the injection. Rash was about 3 inches long by 4 inches wide. Her arm was extremely painful and could not move it. Pharmacist recommended ice and naproxen OTC. Patient returned to the pharmacy on Wednesday October 24, 2018 - rash was resolved, but when pharmacist palpated the patients arm - it was lumpy. Patient still has pain at the area of the injection.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea, Pain in extremity
Clinical narrative: Intense sharp pain down left arm, sweating, nausea, felt like fainting or passing out, shivering after.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Headache, Nervousness
Clinical narrative: Patient felt shaky, developed headache, she said her bp was slightly elevated after about 30 minutes.
Age: 27.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Diarrhea, abdominal pain.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: RN reporting that high dose vaccine given in error, patient only 63. No adverse symptoms reported.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Following injection pt had soreness, Pain, numbness and swelling at site of injection to extreme degree. Felt unable to move arm fully and at times would have to move arm to alleviate pain. Swelling and associated symptoms lasted 2 wks in spite of use of anti-inflammatories, heat, and ice.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: RN reporting that high dose was given in error, patient only 63. No adverse symptoms reported.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Influenza like illness, Injection site pain, Nausea
Clinical narrative: Chills pretty quickly, headaches; sore at injection site. Poor sleeping and feeling "flu-ish" the next day, nausea during the night (no vomiting) and after lunch the second day.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Poor quality sleep
Clinical narrative: Chills pretty quickly, headaches; sore at injection site. Poor sleeping and feeling "flu-ish" the next day, nausea during the night (no vomiting) and after lunch the second day.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Feeling hot, Pruritus, Urticaria
Clinical narrative: Patient received MENACTRA vaccine at 0940 in the right deltoid and was directed to waiting area for check-out. Patient and mother notified clerical staff at 1000 of possible reaction. Patient immediately taken into clinic room. Patient complained of feeling hot and itchy. Patient noted to have small areas of redness to upper right chest. Nickel sized hives to the back of both earlobes.  No airway obstruction, no dificulty breathing. Call made to Dr. medical director who advised 25mg oral Diphenhydramine and observe patient x1 hour. 25 mg oral diphenhydramine administered at 1015 patient improved rapidly with hives resolving at 1100. Pt released at 1115 with referral to PMD for futher evaluation.
Age: 93.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dizziness, Vertigo
Clinical narrative: She experienced extreme dizziness, and the room was spinning. This resolved when she laid down for a few minutes, but continues when she gets up. Her daughter treated her with meclizine, which helped the dizziness, and reached out the PCP. They informed her if she is still having symptoms 72 hours after the vaccine to reach out to the PCP again.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Allergy test, Colonoscopy, Endoscopy, Fatigue, Hypotension
Clinical narrative: I became very ill, started with extreme fatigue, tiredness, low blood pressure, vertigo. Next 6 months, I visited different doctor offices. I had allergy tests done, I had endoscopy and colonoscopy. By the time I diagnosed with ulcer by the July, my symptoms were already starting fades away. By the time doctor put me to the omeprazole for ulcer treatment, I didn't had those severe symptoms that I described. I truly believe flu shot made me very ill and it went away as time passed by. Now I am not sick. I know it was a flu shot, but I don't know exact vaccine name.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Malaise, Ulcer, Vertigo
Clinical narrative: I became very ill, started with extreme fatigue, tiredness, low blood pressure, vertigo. Next 6 months, I visited different doctor offices. I had allergy tests done, I had endoscopy and colonoscopy. By the time I diagnosed with ulcer by the July, my symptoms were already starting fades away. By the time doctor put me to the omeprazole for ulcer treatment, I didn't had those severe symptoms that I described. I truly believe flu shot made me very ill and it went away as time passed by. Now I am not sick. I know it was a flu shot, but I don't know exact vaccine name.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient should have been given a MMR#1 instead of a PROQUAD- pt did not have any negative reactions, however the parent was made aware of the mistake on our part (and was told the risks of febrile seizures after the vaccine, no reaction occured). The employee who made this mistake no longer works here.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 11-OCT-2018, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23, lot# reported as M047619 (lot# was not valid for PNEUMOVAX 23, expiration date: 04-AUG-2018 (exact dose, site and route of administration were not reported). No adverse effects were reported.
Sex: M
Vaccine: PPV
Symptoms: Immunodeficiency, Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 76-year-old male patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date in June 2016, the patient was vaccinated with PREVENAR 13. On an unknown date in August 2016 (reported as 2 months later), the patient was vaccinated with PNEUMOVAX 23 (exact dose, frequency, site and route of administration, lot# and expiration date were not reported) for prophylaxis. The patient was immunocompetent. No adverse effects were reported.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding a 6 months old patient of unknown gender. The patient's pertinent medical conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ, lot # N004817, expiration date: 06-OCT-2018 (dose and route of administration were not reported) for prophylaxis. The vaccines were stored in a temperature of 2 degrees Celsius to 8 degrees Celsius for 4 hours and in 9 degrees Celsius to 25 degrees Celsius for 76 hours (multiple excursions were reported). No previous temperature excursion. Call was due to digital data logger. No adverse effect reported. This is one of the several reports received from same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Needle issue, Wrong technique in product usage process
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a female patient (reported as 41or 43 years) who was vaccinated with a suspect dose of FLUZONE QUADRIVALENT lot UT6290KA (Expiry date: 30-Jun-2019) via intramuscular route in the deltoid on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to wrong injection technique. It was reported that the nurse attempted without the needle for the injection and all the liquid ran down on her arm. It was also a case of exposure via skin contact and a case of needle issue. It was reported that order arrived without the needles attached. 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 and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves Elderly patient (age and gender was not reported) who reported that MD was administering the dose when the syringe leaked from the hub, unclear if patient received a partial dose and syringe at the needle point was leaking at the neck, syringe leaked from the hub while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ047AB and expiry date: 28-May-2019) (dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to underdose and syringe issue. Patient involved reported no known symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a Non-healthcare Professional. This case involves a 58 years old female patient who received FLUZONE HIGH DOSE instead of FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 18-Oct-2018, the patient received a dose 0.5 ml of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ010AC via intramuscular route in the left deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration, Wrong vaccine administered and Overdose accidental. No adverse event was experienced. Reported as has not reported any reaction or adverse effect and has not had any treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This was link case to 2018SA291866. (Same reporter). This case involves a patient of an unknown demographics (age reported as > 65 years) who received an expired dose of vaccine FLUZONE HIGH DOSE (batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date in Aug-2018, which was from last year. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was case of actual medication error due to expired vaccine used. No adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PPV, RVX
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old male patient who was vaccinated with second dose of DTAP-IPV and 0.5 ml second dose of ACT-HIB (Batch number: UIN07AA, expiry date: 26-Oct-2019)via intramuscular route in right thigh instead of PENTACEL (batch number: C5530AA and expiry date: 04-Oct-2019) via intramuscular route in the left thigh and ACT-HIB on 18-Oct-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) and ROTAVIRUS VACCINE LIVE ORAL 1V. It was a case of actual medication error due to wrong vaccine administered and extra dose administered because two vaccines were give in same visit. It was reported as patient was supposed to receive DTaP/IPV vaccine and ACTHIB but was given PENTACEL and ACTHIB at same visit. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Elderly patient (age and gender was not reported) and reported that vaccinated with FLUBLOK QUAD instead of FLUZONE HD, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to Wrong vaccine administered. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Blood pressure increased, Pyrexia
Clinical narrative: Increased BP and fever up to 101.8 degrees. Sent to ER at approximately 10PM on October 16th.  Was released the next morning around 4AM with resolved BP and fever symptoms.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Dyskinesia
Clinical narrative: MENACTRA administered at 1845pm, HPV administered at 1850pm. At 1855pm, noticed pt jerking and leaning on the side, held the pt to prevent fall, informed the MD to come and assess. Pt was assessed by MD pt stated that he felt light headed and dizziness, ordered to rest for 15 mins. Post 15 mins rest, pt verbalized feeling better and was able to ambulate without any assistance. Pt left facility with father A&OX3.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Irritability, Malaise, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Patient complained of excess runny nose, fever, chest congestion, and a general feeling of malaise and crabbiness for about 10 days after receiving the vaccine.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Seizure
Clinical narrative: Patient had a seizure that lasted about 15 seconds in the doctors office a few minutes after the injection. He had another seizure that lasted about 15 seconds on the car-ride home, and also another seizure when he arrived back at the office that is located in location. Patient has not had a seizure in a couple of years and is on anti seizure medications. He gets blood work on a regular basis to watch the levels of the KEPPRA in his blood.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe headache, severe muscle pain: neck, shoulders arms and upper back, chills. Injection site:  swelling, redness, heat, pain, (6" diameter redness). All symptoms (except injection site) resolved within approximately 12 hours. Treatment: ALEVE, TYLENOL Tension Headache.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Tension headache
Clinical narrative: Severe headache, severe muscle pain: neck, shoulders arms and upper back, chills. Injection site:  swelling, redness, heat, pain, (6" diameter redness). All symptoms (except injection site) resolved within approximately 12 hours. Treatment: ALEVE, TYLENOL Tension Headache.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: "Felt numbness and tingling down left arm into 4th and 5th fingers shortly after flu shot given in left deltoid yesterday afternoon. Still feeling tingling in left fingers this morning. Some tingling felt in left foot for a couple of hours. This resolved yesterday."
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Photopsia, Rash erythematous, Rash pruritic, Tinnitus, Vision blurred
Clinical narrative: Within a few minutes my ears began to ring and within 30 minutes my sight got blurry and light flashes seemed to appear, then about an hour to hour and a half I broke out in a itchy bright red rash. I went to the ER and they gave me Prednisone through an IV and Benadryl through an IV and also a bag of fluids through an IV. I was released from the ER around 6:30 to 7:00 pm and had to pick up a prescription for Prednisone 20 mg x3 for 5 days.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Arms/legs rash 9/28 - Treated 10/14. Hands rash 10/19 - Treatment of Diprolene cream 10/22 by Dermatologist. 10/23 MEDROL Dose Pak.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site nodule, Injection site swelling
Clinical narrative: Patient bled immediately upon injection. By the time I applied the bandage, a knot the size of a marble had formed under the skin. It continued to swell and was the size of a golf ball. We applied an ice pack and had her wait about half an hour to see if she had any further reaction. The swelling did go down some by the time she left.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Patient experiencing substantial bruising about 4 inches below the vaccination site....a large band of bruising (purple/red).
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injection site nerve damage, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: I received a flu shot on Tuesday, October 2nd. By that Thursday evening, my arm was swollen and I could not move it up and down or extend it. I saw Dr. on Tuesday, October 9th and she advised me believed that the nurse that administered the shot hit a nerve and she gave me an anti inflammatory and steroid shot. Told me to go to the hospital if it got worse. I went to the hospital after work on Thursday, October 11th. They also believed that the flu shot administered was administered incorrectly. They did a sonogram on my arm to make sure of no blood clots and gave me an anti inflammatory shot and a pain shot. I called Dr. on Monday, October 22nd and advised her that the discomfort and pain I was still having. She told me to contact an Orthopedic doctor. I saw Dr. on Tuesday, October 23rd. He took X-rays of the arm and shoulder and administered a cortisone shot. If not better, I will return in 2 weeks.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound scan normal, Wrong technique in product usage process, X-ray limb
Clinical narrative: I received a flu shot on Tuesday, October 2nd. By that Thursday evening, my arm was swollen and I could not move it up and down or extend it. I saw Dr. on Tuesday, October 9th and she advised me believed that the nurse that administered the shot hit a nerve and she gave me an anti inflammatory and steroid shot. Told me to go to the hospital if it got worse. I went to the hospital after work on Thursday, October 11th. They also believed that the flu shot administered was administered incorrectly. They did a sonogram on my arm to make sure of no blood clots and gave me an anti inflammatory shot and a pain shot. I called Dr. on Monday, October 22nd and advised her that the discomfort and pain I was still having. She told me to contact an Orthopedic doctor. I saw Dr. on Tuesday, October 23rd. He took X-rays of the arm and shoulder and administered a cortisone shot. If not better, I will return in 2 weeks.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Severe body aches, fevers, nausea, vomiting, weakness.
Age: 26.0
Sex: U
Vaccine: HPV9
Symptoms: Injection site nodule, Pain
Clinical narrative: Pain persisting for 3 weeks after injection. There is an injection site nodule on exam. Treatment - warm compress, ibuprofen PRN.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Cellulitis
Clinical narrative: Diagnosed by ER with cellulitis.
Age: 61.0
Sex: F
Vaccine: MMR, VARZOS, MMR, VARZOS
Symptoms: Herpes zoster disseminated, Polymerase chain reaction positive, Varicella virus test positive
Clinical narrative: Disseminated zoster, treated with IV acyclovir. Patient still hospitalized at time of this report.
Age: 61.0
Sex: F
Vaccine: MMR, VARZOS, MMR, VARZOS
Symptoms: Disseminated varicella zoster vaccine virus infection
Clinical narrative: Disseminated zoster, treated with IV acyclovir. Patient still hospitalized at time of this report.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Neck pain
Clinical narrative: Headache occurring several hours after receiving vaccine and is still present. Left sided neck and ear pain started 4 days after receiving vaccine and are still present.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Hypoaesthesia, Injection site oedema, Injection site pain, Paraesthesia
Clinical narrative: Injection site was LUA, medial top of tricep, just lateral to the L axilla area. There is pain at the injection site, an edematous area a few cm's into the axilla from the injection site accompanied with pain, numbness and tingling in the axilla, down the arm and into the fingers. I wanted to take a wait and see approach due to I am not familiar with this vaccine, and the issues I am having would have hopefully resolved but, sadly, they have not. I am going to follow up with my medical provider in the next couple of days.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Axillary mass, Fatigue, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Patient came in 10/22/18 around 5:50pm for a PNEUMOVAX injection. She is a 60 year old smoker. She came in around 4:15 on 10/24/18 and stated she had a rash on her arm that started on 10/23/18. I looked at her arm and found the following: red rash around injection site, left underarm and left shoulder. She stated it was very painful and said she could feel a knot in her underarm area which I'm thinking could possibly be swollen lymph nodes. Patient was not sick at time of vaccination and only received PNEUMOVAX that day. I gave her the vaccination. She stated she felt fine other than the pain from the rash and she felt tired. I told her I didn't think it was severe enough to go to the emergency room. I recommended she either go to urgent care of call her PCP and see if they can see her tomorrow.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Bone pain, Cellulitis, Erythema, Pain
Clinical narrative: Cellulitis and erythema of the left arm, body aches and pain "in the bones", treated with antibiotics, patient was released from the emergency room and returned home.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, CSF protein normal, Computerised tomogram head, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: 10 days after receiving the influenza vaccine, patient seen in emergency department for bilateral lower limb numbness that was ascending in nature over the course of 4 days. She had also started to experience hand numbness as well. Only minimal effects on walking and very little weakness noted. Patient subsequently diagnosed with AIDP/Guillian Barre syndrome by neurologist and required IVIG therapy. Thus far, patient is improving after initiation of IVIG treatment.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: 10 days after receiving the influenza vaccine, patient seen in emergency department for bilateral lower limb numbness that was ascending in nature over the course of 4 days. She had also started to experience hand numbness as well. Only minimal effects on walking and very little weakness noted. Patient subsequently diagnosed with AIDP/Guillian Barre syndrome by neurologist and required IVIG therapy. Thus far, patient is improving after initiation of IVIG treatment.
Age: 4.0
Sex: F
Vaccine: FLU4, HEPA, MMRV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 12 month vaccines that included an extra Hep A and PREVNAR. Child was not supposed receive them and did not receive a DTAP/IPV. Will come back to receive it. No S/S or adverse reactions present.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt came to the store on Wednesday 10/24/2018 and reported soreness, redness, no fever, pain when pressure is put on the site, warm and no trouble sleeping because of vaccine. I told her injection site reactions were common with such vaccine and if gets worse within 2 days she should call the doctor. Apparently later the doctor called and was concerned that the redness was a little bit bigger.
Age: 24.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Tremor
Clinical narrative: Patient was given her first Hepatitis B shot on her right arm. Within 1 or 2 minutes, I administered a seasonal flu shot in her left arm. Immediately after the patient slumped over and started to shake and passed out for 5 seconds. When she came too, the first thing that she asked was how long she was out for. The patient stated that she has episodes of hypoglycemia in the past. I stayed with her, offered her water and gave her 2 glucose tablets to help her feel better. We called 911 and they came and took her to the local ER.
Age: 0.67
Sex: F
Vaccine: FLU4
Symptoms: Ear infection, Pyrexia
Clinical narrative: NO IMMEDIATE EFFECTS; CHILD CALMED DOWN QUICKLY AFTER THE FLU SHOT WAS GIVEN. MOTHER CALLED THE NEXT DAY TO REPORT THAT THE CHILD HAD A LOW-GRADE FEVER BUT ALSO HAD A COLD CURRENTLY. RN ADVISED MOTHER TO CONTACT HEALTH CARE PROVIDER TO SEE IF ANYTHING INDICATED OR IF SHOULD GO IN TO CLINIC. CHILD SPIKED A 102.4 FEVER, AND INFANT WAS BROUGHT IN TO WALK-IN CLINIC OVER THE WEEKEND (SATURDAY, 2 DAYS AFTER SHOT). INFANT WAS DIAGNOSED WITH DOUBLE-EAR INFECTION. GIVEN ACETAMINOPHEN TO BRING DOWN FEVER. MOTHER REPORTED THIS INCIDENT TO RN ON WEDNESDAY THE FOLLOWING WEEK AND ASKED THAT IT BE REPORTED AS A POSSIBLE ADVERSE REACTION TO FLU VACCINE DUE TO THE CLOSE PROXIMITY OF GETTING THE FLU SHOT AND SPIKING A FEVER AND HAVING A DOUBLE-EAR INFECTION.
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Burning sensation, Chills, Erythema, Feeling hot, Rash erythematous
Clinical narrative: One hour after receiving the injection, I developed a red, maculopapular rash, starting on my forehead and face/neck. It spread to my chest/trunk and feet by the afternoon. I felt warm, as if I had a sunburn on my face and neck/ears, yet had some chills. No cough/runny nose/difficulty breathing/scratchy throat. I took a BENADRYL in the afternoon with minimal improvement. One of my partners (I am a family physician) gave me 40mg of prednisone, which helped reduce the redness and burning overnight; however, redness and rash is still present today. I will continue prednisone today.
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash maculo-papular
Clinical narrative: One hour after receiving the injection, I developed a red, maculopapular rash, starting on my forehead and face/neck. It spread to my chest/trunk and feet by the afternoon. I felt warm, as if I had a sunburn on my face and neck/ears, yet had some chills. No cough/runny nose/difficulty breathing/scratchy throat. I took a BENADRYL in the afternoon with minimal improvement. One of my partners (I am a family physician) gave me 40mg of prednisone, which helped reduce the redness and burning overnight; however, redness and rash is still present today. I will continue prednisone today.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Erythema, Headache, Induration
Clinical narrative: Patient received FLULAVAL vaccine 10/23/18 right deltoid muscle. No adverse reaction after 15 minutes. 10/24/18 office visit for possible reaction to flu vaccine. Patient complains of stomachache, headache and rash to right upper arm. Right arm erythema 4.5in x 1.4in, mild induration.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Blood calcium, Blood parathyroid hormone, Cognitive disorder, Computerised tomogram
Clinical narrative: Arm swellling rash itching, loss of cognitive function/ short term memory.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash pruritic
Clinical narrative: Arm swellling rash itching, loss of cognitive function/ short term memory.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised, Swelling face
Clinical narrative: Swollen face and itching around the body.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Product administered at inappropriate site, X-ray limb
Clinical narrative: Injection given too high in the arm. Now have reduced/limited movement of the arm due to pain, shoulder joint hurts, deltoid muscle aches.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Herpes zoster, Inflammation, Pruritus, Rash, Rash erythematous
Clinical narrative: Patient was given an MMRV around 4pm in left arm. The next day she had itching and a red rash on right shoulder/back. Visit with Dr. on 10/22/18 it was diagnosed as shingles. She returned to clinic on 10/24/18 with rash less inflamed and pustules crusted. Stated it was more itchy than painful now.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash pustular, Scab
Clinical narrative: Patient was given an MMRV around 4pm in left arm. The next day she had itching and a red rash on right shoulder/back. Visit with Dr. on 10/22/18 it was diagnosed as shingles. She returned to clinic on 10/24/18 with rash less inflamed and pustules crusted. Stated it was more itchy than painful now.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Redness, fever and arm pain.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Neck pain, Pain in extremity
Clinical narrative: Day 1. Arm sore, neck ache, headache. Day 2-5 Slight redness at injection site. Day 6 Very bright red from injection site to elbow. Called Doctor. Advised to use warm, moist compress. No tenderness or fever, so just monitor.