chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Electrocardiogram normal, Mobility decreased, Neck pain, Pain in extremity, Pallor
Clinical narrative: patient presented to emergency room with sore right arm and pain radiating up to neck, breathing fast, and color out of face. EKG performed and it came back normal. Patient also had difficulty lifting arm above head. There was no problem at the site of the injection. He was told to ice, use Tylenol. The patient called by the pharmacist after 72 hours and is improving now
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Respiratory rate increased
Clinical narrative: patient presented to emergency room with sore right arm and pain radiating up to neck, breathing fast, and color out of face. EKG performed and it came back normal. Patient also had difficulty lifting arm above head. There was no problem at the site of the injection. He was told to ice, use Tylenol. The patient called by the pharmacist after 72 hours and is improving now
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Hyperhidrosis, Pain
Clinical narrative: Severe chills, then sweating, headache, body aches, severe fatigue lasting 24 hours for both doses.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Severe chills, then sweating, headache, body aches, severe fatigue lasting 24 hours for both doses.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Arthralgia, Headache, Injection site pain, Musculoskeletal pain
Clinical narrative: Palpitaions in right upper chest, then pain in injection sited that extende down arm, also in opposite arm. Followed by then joint pain in shoulders, that then spread to all my joints, with intense pain in neck. Headache and then after about 4 hours after start of reaching stomach pain and nausea.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Neck pain, Pain in extremity, Palpitations
Clinical narrative: Palpitaions in right upper chest, then pain in injection sited that extende down arm, also in opposite arm. Followed by then joint pain in shoulders, that then spread to all my joints, with intense pain in neck. Headache and then after about 4 hours after start of reaching stomach pain and nausea.
Age: 8.0
Sex: M
Vaccine: DT
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pain, Pruritus
Clinical narrative: red, hot, hard area around injection site approx. 4 inchs by 4 inches. Child complained about pain and itching day 2 post injection. Went to ER day 2 started motrin, benadryl with intermittent ice.  Day three the redness grew larger continued motrin, benadryl, and intermittent ice.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient returned to pharmacy approx 2 weeks later saying he has been experiencing shoulder pain ,possibly nerve related since shot ws given
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Induration, Injection site discomfort, Pruritus, Skin warm
Clinical narrative: Patient came to clinic stating arm was very itchy and red. Arm was indeed red, warm, and hard to the touch. Patient stated itchyness began the day after receiving the vaccine, and today (two days later) it was extremely itchy. Patient was told to monitor the site, take Tylenol/Motrin for the discomfort and to use Hydrocortisone cream on arm to help with itchyness. Pharmacy provided all medications to patient.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Skin warm
Clinical narrative: Sore arm for 5 days, warm to touch, 3x3 in rash
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: HOT TO TOUCH RED SWELLING ABOUT 3 BY 5 INCHES
Age: 72.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Arthralgia, Disorientation, Eyelid ptosis, Flushing, Myalgia
Clinical narrative: 2 hours after receiving these vaccinations the patient had started to feel disoriented.  By 9:30pm that night he felt aches in his muscles and experienced a flushed feeling.  The next morning, 10/2, he had pain in his joints and a droopy eye.  He was able to see the doctor on 10/2, but by the time he was in the office the symptoms had resolved.  I spoke with the patient on 10/3 midday and he said that his symptoms were all improving over today.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient has had a fever of 102.8 since this afternoon, has been treating with ibuprofen. Counseled to continue pain medication and see a physician if it continues or gets any worse.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: painful injection site, red, hard to touch and warm. pt can't lift his arm
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Ocular hyperaemia, Uveitis
Clinical narrative: Patient developed uveitis in the right eye.  Patient was treated by opthalmologist starting 8/8/19 with prednisolone eye drops from 8/8/19 until current time and cyclogyl drops from 8/8/19 until 8/13/19.  Patient reported achy dull eye pain with redness (similar to conjunctivitis) for the first two to three days after vaccine administered.  Patient self treated with ibuprofen 200 mg with no improvement in symptoms for two days. She then went to primary care on 08/07/2019 and was prescribed polymyxin b - trimethoprim eyedrops which she used for one day before going to opthalmologist.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: patient started experiencing swelling, pain and redness the day after vaccine. got worse and more painful and patient decided to visit doctor. he diagnosed her with cellulitis
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: PAtient got chills seats and experienced shaking
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Impaired work ability, Induration, Mass, Pain
Clinical narrative: Have received the flu vaccine every year without incident and was 100% well when I received it. Received my vaccine at 12pm. By 2 pm had hot hard painful lump so I took 1 gram of oral tylenol. By 4pm had 101 fever and lump had increased to 4 inches in diameter and was raised 1 inch from surrounding tissue applied an ice pack for half hour. By 8 pm that night lump had increased to six inches in diameter and remained one inch raised and it was incredibly painful home from work at that time and ice pack applied, temperature remained >101 degrees. Fell asleep, woke up at 2300 with 102.7 temp and rigors. Lump in arm remained 6 inches in diameter and incredibly painful. Took another gram of tylenol and reapplied ice. Continued to have a fever >101 until the morning of October 3 despite taking antipyretics around the clock. In the morning of Oct 3 noted that the lump with still 6 inches in diameter but not nearly as raised or hard and less painful than previously. Notified my employee health RN as I had received the vaccine at work which is mandatory by my employer. i did end up missing one day of work on October 2nd as I still had a fever 101-102 degrees.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: Have received the flu vaccine every year without incident and was 100% well when I received it. Received my vaccine at 12pm. By 2 pm had hot hard painful lump so I took 1 gram of oral tylenol. By 4pm had 101 fever and lump had increased to 4 inches in diameter and was raised 1 inch from surrounding tissue applied an ice pack for half hour. By 8 pm that night lump had increased to six inches in diameter and remained one inch raised and it was incredibly painful home from work at that time and ice pack applied, temperature remained >101 degrees. Fell asleep, woke up at 2300 with 102.7 temp and rigors. Lump in arm remained 6 inches in diameter and incredibly painful. Took another gram of tylenol and reapplied ice. Continued to have a fever >101 until the morning of October 3 despite taking antipyretics around the clock. In the morning of Oct 3 noted that the lump with still 6 inches in diameter but not nearly as raised or hard and less painful than previously. Notified my employee health RN as I had received the vaccine at work which is mandatory by my employer. i did end up missing one day of work on October 2nd as I still had a fever 101-102 degrees.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Eye pain, Ocular hyperaemia, Vision blurred
Clinical narrative: Pt became with dizziness; denies near syncope, BP well controlled, no fever, SOB, HA, palpitations, chills. Pt called clinic at 4:55pm 10/2/19 spoke to RN who ordered the vaccine and assessed pt this morning. Pt also received the flu shot with no hx of reactions to flu shot. Pt given ER precautions.  On 10/3/19 pt states eye pain in both eye and redness. No discharge, no headache, just dizziness, blurry vision and eye pain bilaterally. Pt given ER precautions for worsening pain and appt made for eye exam tomorrow in clinic 10/4/19
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash macular, Scab
Clinical narrative: The day following the vaccination he developed yellow blotches on both medial lower legs which to him looked like hives.  The next day he developed generalized pruritus and clusters of water blisters in streaks on arms and legs and beneath his nose. The following day it dawned on him that these tiny blisters were identical to what he had seen in the past on his genitalia during outbreaks of herpes.  So he began the same regimen of treatment which had been effective for his herpes outbreaks.  Within eight hours of the first dose of 2 grams of valacyclovir the pruritus had resolved.  Twelve hours later he took the second dose and soon thereafter the water blisters began crusting over.  Just to be sure he repeated the course the following day.  The rash and all of his symptoms quickly resolved and he has remained asymptomatic since.  He first reported this to me today when he was in my office for an unrelated matter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Lethargy
Clinical narrative: I woke up at 3 am shivering uncontrollably, with chills and a low grade fever.  After taking Tylenol, I fell back asleep an hour later. I got up at 7 am, but was extremely weak, lightheaded, and lethargic. I went back to bed by 8 am and slept until 1 pm. I awoke with a fever and chills again.  It is now 7 pm, and I no longer have chills, but I am still very weak and lightheaded. I also have no appetite.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I woke up at 3 am shivering uncontrollably, with chills and a low grade fever.  After taking Tylenol, I fell back asleep an hour later. I got up at 7 am, but was extremely weak, lightheaded, and lethargic. I went back to bed by 8 am and slept until 1 pm. I awoke with a fever and chills again.  It is now 7 pm, and I no longer have chills, but I am still very weak and lightheaded. I also have no appetite.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Pt states she received the immunizations on 9/30/19.  The next day she woke up and her right arm (the arm with influenza and PPSV 23) was red and painful.  She also states she has ran a low grade fever since she received the immunizations.  She states that there was a short time her fever went up to 102 but went back down.  Pt states she has used ice packs and ibuprofen.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLU3, PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Pt states she received the immunizations on 9/30/19.  The next day she woke up and her right arm (the arm with influenza and PPSV 23) was red and painful.  She also states she has ran a low grade fever since she received the immunizations.  She states that there was a short time her fever went up to 102 but went back down.  Pt states she has used ice packs and ibuprofen.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Decreased appetite, Somnolence, Tremor
Clinical narrative: said she had "the shakes", loss of appetite, drowsiness, loss of balance for 1-2 days after the shot
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Dizziness, Fatigue, Injection site pain
Clinical narrative: Within an hour of the shot in my non-dominant arm, I started to feel unusually sore. By 8 p.m. in the evening, I started to get the chills and by 9 p.m., my entire body was aching painfully. By 10 p.m., I was trembling from the chills, could barely move from the aches, and started to get dizzy. I went to bed immediately. The next day, I still felt somewhat achy, but it felt like the pain from the shot was more localized in my left shoulder and the left side of my jaw. The chills were mostly gone. I took two doses of advil (two capsules each time) during the day.  By the evening of day 2 (~36 hours after the shot), I still felt very tired and the aches were starting to come back in my left shoulder and lower back. The exhaustion continues.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Pain in jaw, Tremor
Clinical narrative: Within an hour of the shot in my non-dominant arm, I started to feel unusually sore. By 8 p.m. in the evening, I started to get the chills and by 9 p.m., my entire body was aching painfully. By 10 p.m., I was trembling from the chills, could barely move from the aches, and started to get dizzy. I went to bed immediately. The next day, I still felt somewhat achy, but it felt like the pain from the shot was more localized in my left shoulder and the left side of my jaw. The chills were mostly gone. I took two doses of advil (two capsules each time) during the day.  By the evening of day 2 (~36 hours after the shot), I still felt very tired and the aches were starting to come back in my left shoulder and lower back. The exhaustion continues.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient experience bruising mainly in the left triceps area with spotty bruising in the left bicep area. The bruises are not near the deltoids area but below it. Per patient, the bruising has spread. Recently the bruising extends down to her elbow
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Musculoskeletal pain
Clinical narrative: Patient was fine upon leaving  pharmacy on 10/01/19. Called on 10/03/19 and reported via telephone swelling at injection site and extreme shoulder pain.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Back pain, Headache, Influenza like illness, Mobility decreased
Clinical narrative: per pt she felt back pain, headaches, flu like symptoms during the first 24 hours after taking both. she stated that its her second dose of shingrex and she did not feel bad. But when taken with fluzone she felt like she could not get out of bed the next day.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Dyspnoea, Speech disorder
Clinical narrative: The patient received both immunizations and started to leave the store. A few minutes later she had walked back to the pharmacy. After checking on her, she was having an extremely difficult time breathing, could barely speak a couple of words. She tried to give herself a puff of albuterol and after a couple of minutes she was still having trouble breathing and had no improvement. 911 was called for assistance. I administered one dose of epinephrine into her right thigh. A few moments after the injection she was able to breathe without any difficulty. She did complain of hip pain post epihephrine but remained stable until EMS arrived.
Age: 56.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia, Paraesthesia
Clinical narrative: Per patient's oral history, he experienced some typical muscle soreness characteristic of previous vaccinations on days 1-2 postvaccination. Vaccines were given 1 inch apart in the same deltoid. After initial day or 2, patient experienced some redness and swelling (more itchy than painful per his report) starting a few inches below the injection site and spreading downward and medially toward his bicep/inner elbow. He said thinking it may have been an insect bite he did apply OTC hydrocortisone to the initially reddened area (starting approx. 3-4 inches below the injection site). This area has cleared up but there is still some minor redness/puffiness on the patient's bicep proximal to the inner elbow. Patient also complains of some tingling in right fingertips, and depending on arm position occasionally escalates to "pins and needles" sensation. Upon assessment of initial injection site IM injections appear placed appropriately about 3 inches down from acromion process. Redness appeared distal to injection site according to patient's report. Visible erythema seems to have almost cleared up, but due to paresthesia side effect advised patient that if this symptom is unremitting after the weekend (4 days' time) to seek further care and follow up.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Dizziness, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever, light headed, dizzy, stiff Limbs, cold chills.
Age: 0.08
Sex: F
Vaccine: UNK
Symptoms: Jaundice, Liver disorder
Clinical narrative: Jaundice, liver filling with toxins
Age: 51.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Erythema, Inflammation, Peripheral swelling, Pruritus
Clinical narrative: Pt stated that her arm was itchy and upon looking it was red and swollen. When pt presented to the pharmacy the majority of her bicept was red and swollen. She purchased some Benadryl to take and was going to keep an eye on any worsening symptoms or spreading of the inflamed area.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Bone pain, Headache, Immediate post-injection reaction, Influenza like illness
Clinical narrative: Immediate pain in left arm spread to elbow and across breast bone. Flu like symptoms nausea joint pain headache fever of 103 went to ER and followed up with my physician
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pain in extremity, Pyrexia, White blood cell count increased
Clinical narrative: Immediate pain in left arm spread to elbow and across breast bone. Flu like symptoms nausea joint pain headache fever of 103 went to ER and followed up with my physician
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Area of large local inflammatory redness encompassing entire left upper arm at site of flu vaccine one day prior
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Heart rate decreased, Muscular weakness, Peripheral coldness, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Seen 9/27/19 for (L) distal arm weakness. Noted to have decreased pulses & cool (L) hand. Doppler showed thrombus (L) brachial/ulnar/radial artery thrombus. Now known family history known of emboli/thrombi.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) upper arm red and swollen AM after vaccine administration. Apply cold compresses Will put a Note in chart to monitor for reactions for future vaccines.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Rash: small red unraised rash itched
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Bone pain, Discomfort, Joint range of motion decreased, Myalgia, Neuralgia
Clinical narrative: patient called stating limited range of motion, pain, tingling. Visited primary provider. Concern of muscle, nerve, bone pain continuing. Patient reports having a feeling of pressure/resistance on injection. Concern is that discomfort is continuing one month later.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Paraesthesia
Clinical narrative: patient called stating limited range of motion, pain, tingling. Visited primary provider. Concern of muscle, nerve, bone pain continuing. Patient reports having a feeling of pressure/resistance on injection. Concern is that discomfort is continuing one month later.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red, swollen Arm
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Injection site erythema, Injection site pruritus, Nausea, Throat irritation
Clinical narrative: Patient was given vaccination and almost immediately had redness + itching at the injection site. She put ice on it and was given 25mg IM diphenhydramine 45 min later she developed an itchy/burning throat, shortness of breath and nausea. She was given another 25mg IM diphenhydramine but did not improve so she was sent to the emergency room with an epi pen just in case
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain, Swelling
Clinical narrative: Patient contacted us complaining of swelling and pain which began immediately after injection. I explained that if this is continuing, contact her physician to prevent a possible allergic reaction. She wanted me to fill this adverse event form out.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Injection site urticaria
Clinical narrative: Hives- around shot site. Ibu & Benadryl given in clinic spoke with Mom @ 3:10pm. Sx have resolved.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Back pain, Lethargy, Neck pain
Clinical narrative: Patient complained of pain in multiple joint areas including wrist, hips, back & neck plus generalized "lethargy" - all for 5 days.
Age: 83.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash on (R) arm that came up the day after she got shingrix #1 vaccination in that arm. Rash started distal to (R) axilla + was painful + itchy. Used Cortisone + it didn't help. Rash spread to ears, neck, chest, back, legs, feet bilaterally
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Eye swelling
Clinical narrative: Eye swelling for 2 days. Resolved. Sx began 1 day after vaccine No tx.
Age: 1.58
Sex: M
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Redness 10 cm
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza, Pneumonia
Clinical narrative: Flu Symptoms a day after Shot Patient states The immunisation Gave her Pneumonia.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection, Injection site swelling
Clinical narrative: pt developed large swollen area at injection site. Was seen by Dr. and was given Cephalexin 500 1 PO TID x 7days due to MD believing it was a bacterial infection caused by vaccine
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in ARM after injection
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient's whole upper arm and shoulder began hurting immediately after vaccination and has continued to hurt. She has had trouble lifting or reaching with the arm. Patient stated she works at Hospital and questioned a nurse practitioner who felt the injection was given too high but should resolve within 6 weeks.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site swelling
Clinical narrative: Swelling IN Bicep of Injection ARM. Redness in large area of upper ARM. Started Next Day IN morning.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone High Dose was administered to a 57 year old patient, no AE; Fluzone High Dose was administered to a 57 year old patient, no AE; Initial information received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office Staff).  This case involves a 57 years old male patient who was vaccinated with vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22 Sep 019, the patient received a 0.5 ml 1 dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ238AB, EXP: 04/14/2020 via unknown route in the left deltoid.  It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of documents held by the sender: none
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluzone High Dose was administered to a 57 year old patient, no AE; Fluzone High Dose was administered to a 57 year old patient, no AE; Initial information received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office Staff).  This case involves a 57 years old male patient who was vaccinated with vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22 Sep 019, the patient received a 0.5 ml 1 dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ238AB, EXP: 04/14/2020 via unknown route in the left deltoid.  It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of documents held by the sender: none
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Fluzone High Dose was administered to a 57 year old patient, no AE; Fluzone High Dose was administered to a 57 year old patient, no AE; Initial information received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office Staff).  This case involves a 57 years old male patient who was vaccinated with vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22 Sep 019, the patient received a 0.5 ml 1 dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ238AB, EXP: 04/14/2020 via unknown route in the left deltoid.  It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of documents held by the sender: none
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Pnuemovax and fluzone HD administered on right deltoid on the 09/30/2019, pt came back to the pharmacy on 10/04/2019 to report redness, swelling and low-grade fever that started the day after administration
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLU3, PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Pnuemovax and fluzone HD administered on right deltoid on the 09/30/2019, pt came back to the pharmacy on 10/04/2019 to report redness, swelling and low-grade fever that started the day after administration
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus
Clinical narrative: Staff complained of itching  mild redness to neck, arm and back  after Flu vaccine was given- referred to urgent care was given bemadryl and breathing treatment
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Eye pain, Headache, Injection site pain, Ocular hyperaemia
Clinical narrative: Red sore eyes and  some pain in arm  on October 2, 2019 at 5 pm.  No treatment. Pain in left arm and elbow on October 2, 2019 at 10 pm. Ibuprofen and Tylenol. Excruciating pain in left arm, elbow, shoulder, and spine and headache on October 3, 2019 at 8:30 pm.  Headache pain relief (acetaminophen 250 mg / aspirin 250 mg / caffeine 65) and  massage. Headache pain was relieved, left arm and shoulder pain relieved,  but still spine pain.  Right shoulder beginning to hurt as well.  Diclofenac Sodium Topical Gel 1%.  Less pain except for spine.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Spinal pain
Clinical narrative: Red sore eyes and  some pain in arm  on October 2, 2019 at 5 pm.  No treatment. Pain in left arm and elbow on October 2, 2019 at 10 pm. Ibuprofen and Tylenol. Excruciating pain in left arm, elbow, shoulder, and spine and headache on October 3, 2019 at 8:30 pm.  Headache pain relief (acetaminophen 250 mg / aspirin 250 mg / caffeine 65) and  massage. Headache pain was relieved, left arm and shoulder pain relieved,  but still spine pain.  Right shoulder beginning to hurt as well.  Diclofenac Sodium Topical Gel 1%.  Less pain except for spine.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Headache, Nausea, Pain, Pyrexia
Clinical narrative: nausea, stomach pain, vomiting, fever, body aches, headache. Vomiting in night. Other symptoms all night and following day
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: nausea, stomach pain, vomiting, fever, body aches, headache. Vomiting in night. Other symptoms all night and following day
Age: 25.0
Sex: F
Vaccine: ANTH, JEV1, SMALL
Symptoms: Maternal exposure before pregnancy, Pregnancy test urine positive
Clinical narrative: On 4 OCT 2019, PT discovered that she has been in positive on urine pregnancy test after she received the smallpox on 24 SEP 2019.
Age: 28.0
Sex: F
Vaccine: FLU4, HEPA, PPV, TDAP
Symptoms: Laboratory test normal, Leukocytosis, Local reaction, Urticaria, White blood cell count increased
Clinical narrative: Large local reaction started about 6 hours after the vaccines were administered.  Urticaria developed two days later.  Patient was seen in the Emergency Department for this reaction.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site reaction, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: First sign that appeared was soreness in the arm. This started approximately 2 hours after vaccination. By hour 4 after vaccination, the arm was so stiff that it was hard to move. At hour 6, the injection site was inspected for the first time. There was a bright red welt with an approximate 1 inch diameter; the welt was giving off a large amount of heat. The following morning, the welt had grown to approximately 2.5 inches in diameter. The arm was still extremely sore and difficult to move without pain. The soreness and pain went down as time went on. Today, five days after the vaccine, the welt is finally gone, but there is still residual muscle soreness.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Pain, Pain in extremity, Urticaria
Clinical narrative: First sign that appeared was soreness in the arm. This started approximately 2 hours after vaccination. By hour 4 after vaccination, the arm was so stiff that it was hard to move. At hour 6, the injection site was inspected for the first time. There was a bright red welt with an approximate 1 inch diameter; the welt was giving off a large amount of heat. The following morning, the welt had grown to approximately 2.5 inches in diameter. The arm was still extremely sore and difficult to move without pain. The soreness and pain went down as time went on. Today, five days after the vaccine, the welt is finally gone, but there is still residual muscle soreness.
Age: 65.0
Sex: F
Vaccine: PPV, SMALL
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Swelling at site of injection. Redness, Skin is hard. Skin is hot. Fever, nausea and pain at site of injection. These symptoms occurred within 24 hours and today is day three after the injections. Symptoms remain. I did contact the doctor on the day after injections to let him know about the reactions. He said next year they will give them in separate sites as these were given in the same site. And perhaps on different days.
Age: 65.0
Sex: F
Vaccine: PPV, SMALL
Symptoms: Pyrexia
Clinical narrative: Swelling at site of injection. Redness, Skin is hard. Skin is hot. Fever, nausea and pain at site of injection. These symptoms occurred within 24 hours and today is day three after the injections. Symptoms remain. I did contact the doctor on the day after injections to let him know about the reactions. He said next year they will give them in separate sites as these were given in the same site. And perhaps on different days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Feeling abnormal, Lethargy, Pain
Clinical narrative: Started with body aches, fever, lethargy, exhaustion developed cough lasted for 5 days.  Cough still lingers now on day 6.  Haven?t felt this bad in a very long time.  Felt it important to report this.  2nd dose.  No real reaction after first except a little soreness. Crazy. Why this reaction?
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Started with body aches, fever, lethargy, exhaustion developed cough lasted for 5 days.  Cough still lingers now on day 6.  Haven?t felt this bad in a very long time.  Felt it important to report this.  2nd dose.  No real reaction after first except a little soreness. Crazy. Why this reaction?
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Product administered at inappropriate site, Skin lesion, Skin warm, Tenderness
Clinical narrative: Patient presented to clinic with cellulitis at vaccination site. The site at which the patient was immunized is lower than the recommended distance from the acromion process. Approximate 10cm lesion at time of appointment. Patient denied shortness of breath or difficulty breathing, no generalized rashes present, negative for axial lymphadenopathy. Lesion was erythemic and hot to touch, tender to palpation. Physician Assistant prescribed Keflex for treatment. Patient advised to follow up with the clinic if his symptoms do not improve.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination site cellulitis
Clinical narrative: Patient presented to clinic with cellulitis at vaccination site. The site at which the patient was immunized is lower than the recommended distance from the acromion process. Approximate 10cm lesion at time of appointment. Patient denied shortness of breath or difficulty breathing, no generalized rashes present, negative for axial lymphadenopathy. Lesion was erythemic and hot to touch, tender to palpation. Physician Assistant prescribed Keflex for treatment. Patient advised to follow up with the clinic if his symptoms do not improve.
Age: 60.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Chills, Insomnia, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: Muscle soreness, chills, fever, stiffness,  insomnia. Took Tylenol. Symptoms abated after 24 hours.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Muscle discomfort
Clinical narrative: Patient reports to muscle discomfort and limited movement 3 weeks after vaccine
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Peripheral swelling
Clinical narrative: a horrible local reaction with swelling and redness on the arm; a horrible local reaction with swelling and redness on the arm; it had gotten worse everyday for at least 3 days; This spontaneous report has been received from a pharmacist via a company representative referring to a 62 years old female patient. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot #, expiration date, dose and route of administration were not provided) for prophylaxis.   On an unspecified date, she experienced a horrible local reaction with swelling and redness on the arm and it had gotten worse (disease progression) every day for at least 3 days. The outcome of all the events was not recovered. It was unknown if treatment was given or lab diagnostics/studies were performed for the events.  The causality between varicella virus vaccine live (Oka/Merck) (VARIVAX) and all the events was not provided.
Sex: F
Vaccine: PPV
Symptoms: Accidental exposure to product, Needle issue, No adverse event, Skin laceration
Clinical narrative: medical assistant administering the dose was cut on her hand from the broken edge.; Syringe number one broke at the finger flanges during administration/the dose was cut on her hand from the broken edge; product quality complaint; Syringe number one broke at the finger flanges during administration; THE NEEDLE APPEARED CROOKED; This spontaneous report was received from a pharmacist referring to a female patient of unknown age, who was not pregnant. No concurrent, conditions, medical history or concomitant therapies were provided.  On 18-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route were not provided) for prophylaxis. Lot No. S012245 has been verified to be a valid lot number for [pneumococcal vaccine, polyvalent (23-valent)], expiration date reported as 09-FEB-2021, and upon internal validation established as the same.  On this same date, during the vaccine administration two vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringes out of a carton of ten broke.   The first syringe broke at the finger flanges while using it, but there was no initial crack on the syringe. The finger flanges broke up after the administration of the shot (product quality issue). The medical assistant was administering the dose and was cut on her hand from the broken edge (skin laceration; accidental exposure to product). The patient who received the vaccine reported no adverse effects. There was no difficulty trying to attach the syringe needle to the syringe, but the needle appeared crooked (needle issue). The medical assistant saw the physician and the physician cleaned up the cut and bandaged it. The outcome of skin laceration was reported as resolved on 20-SEP-2019.  The second syringe broke at the luer lock while the medical assistant was sliding the safety tip off of the needle. It was stated that it broke after administration while attempting to put the safety mechanism on after administration. No patient was involved.   The outcome of product quality issue, accidental exposure to product, needle issue and syringe issue was unknown.     The reporter did not provide a causal relationship between the events and the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one dose of an improperly stored vaccine ROTATEQ to one patient; This spontaneous report was received from a nurse and concerns to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.         On 12-SEP-2019, the patient was vaccinated with an improperly stored dose of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  lot # R030924 and expiration date 10-JUL-2020, for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 0.24 degrees Celsius (multiple) for 5 hours and 30 minutes, as recorded by a data logger. There was no  previous temperature excursion. No adverse effect reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; the patient was inadvertently administered a dose of PROQUAD; This spontaneous report was received from the vaccine coordinator and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and historical drugs was not provided.  On 24-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rha)(PROQUAD) (strength, dose, route and anatomical location were not provided) for prophylaxis. The following lot numbers were reported: lot # R030805 with expiration date on 22-APR-2020 and lot # S003326 with expiration date on 02-AUG-2020.  The vaccine was exposed to a temperature of 27.1 degrees fahrenheit during 40 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. No adverse effects were reported. The vaccine was reconstituted with properly sterile diluent.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: pneumonia; This spontaneous report was received from a pharmacist regarding a 74 year old female patient. Information on medical history, concurrent condition, concomitant medications and drug reactions/ allergies were unknown.  Approximately on an unspecified date in 2014 when she was over 65 years of age, (Also reported as about five years ago), the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, therapy duration, route, anatomical location, lot # and expiry date were unknown) for prophylaxis.   Approximately on an unspecified date in 2018 (Also reported as last year), the patient experienced pneumonia. On an unspecified date, the patient was hospitalized due to event for an unspecified period of time. The patient received unspecified treatment for the event.  The outcome of the event pneumonia was reported as recovered. The causality assessment was not provided. There was no product quality complaint associated with this reported.    Upon internal review, the event pneumonia was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; A patient was administered improperly stored PROQUAD; This spontaneous report was received from a pharmacist referring to a 4-year-old patient of unknown gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On 09-SEP-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (strength, dose, frequency and route of administration were not provided) (lot # S009759 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 27-SEP-2020). A sterile diluent properly stored was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).   The temperature of storage and time frame of the excursion were 15°F (Fahrenheit) to 46°F (17.6°F) and 56 hours and 40 minutes respectively, a previous temperature excursion was at 6°F to 14°F (6.2°F) for 10 minutes. A datta logger was not used. No adverse effect was reported
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient was adminitered improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a 4-year-old patient of an unknown gender. Information about the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies were not provided. The concomitant medications included sterile diluent.  On 04-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) for prophylaxis, lot number S009759 and expiration date 27-SEP-2020 (strength, route of administration and anatomical location were not provided) (product storage error).  The vaccine was exposed to a temperature excursion of 17.6-Farenheit degree (F) (range from 15º F to 46º F) for 56 hours and 40 minutes. There was a previous temperature excursion of 6.2º F (range from 6º F to 14º F) for 10 minutes. There was no digital data logger involved.  It was reported that the sterile diluent that was used to reconstitute the vaccine was properly stored.   There were no adverse effects reported.
Sex: M
Vaccine: MMRV
Symptoms: Rash, Throat tightness
Clinical narrative: a bad rash; constricted throat; This spontaneous report was received from the patient's mother and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis (strength, dosage, frequency, route, lot# and expiration date were not provided).        On an unknown date, the patient experienced a bad rash and constricted throat (throat tightness).     The outcome of rash and throat tightness was unknown.        The reporter did not provide causality assessment between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects noted; the patient received an expired dose of PROQUAD; This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.  On 02-OCT-2019, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R008205 (expiration date: 16-SEP-2019), subcutaneously in the left deltoid for prophylaxis. No adverse effects noted.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Signs of cellulitis at the injection site; This spontaneous report has received from an officer manager through a company representative, regarding to a 72-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 24-SEP-2019, the patient was vaccinated with a dose pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S013490, has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), expiration date not reported, but upon internal validation established as 06-MAR-2021 (strength, dose, route of administration and anatomical location of vaccine were not provided) for vaccination.   On 26-SEP-2019, the patient returned to the facility with signs of cellulitis at the injection site (Injection site cellulitis); however, she sought for medical atention and an unspecified physician placed the patient on antibiotic (unspecified treatment). At the reporting time, the outcome of injection site cellulitis was unknown.  The causality assessment between the injection site cellulitis and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.