chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Sneezing, Urticaria
Clinical narrative: 10/17/19 evening, pt reported hives approx 6.5x4.5 inches wide, bruising at injection site, exacerbation of asthma symptoms: sneezing, coughing, itching, fever of 100.6 max, severe drainage;  pt contacted dr. and dr recommended pt receive qvar, benadryl, and hydrocortisone to treat and to contact pharmacy to fill a vaers.  pt states is feeling better and would like to report that she suspects eggs used in birds that may have been fed tree nuts.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a delayed adverse reaction one week after vaccination was given. She complained of a red, raised and warm area at site of vaccination. Patient was instructed to use cold compressed and acetaminophen. Benadryl was suggested for an allergic reaction/ more severe reaction. Patient was instructed to follow up with PCP and go to ER if condition gets worse/ patient notices signs and symptoms of severe allergic reaction.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching at injection site,  Patient was advised to take Benadryl and apply ice.  Symptoms improved the next day with the benadry and the ice.  Symptoms resolves 2 days after administration.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: right half of abdomen is red and hot. patient realized it upon waking up this morning. patient will be contacting PCP today.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient presents to pharmacy with pain and swelling in left arm, and complains unable to lift arm nor get dressed.  I have advised patient to see her doctor for full evaluation.  Patient was unable to see her doctor today, Oct 21,2019 as a walk in patient.  She will return with results from her doctor.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was due for Pneumovax23 and received and second dose of Prevnar13 after 1 year instead. No adverse event occurred.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Vomiting
Clinical narrative: My sister is recovering from cancer and she was given a flu vaccine and a "pneumonia" shot at her oncologist's office.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Bed rest, Muscular weakness, Pyrexia, Tremor
Clinical narrative: Fever 102 degrees,  tremors,  muscle weakness began about 2 hours after the vaccine.  Bed bound for 3 days after the vaccine due to weakness and shaking.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Hyperkeratosis, Parakeratosis
Clinical narrative: He under went Derm eval for the extent of involvement of his arms, trunk, legs and  was diagnosed with "hyperkeratosis with parakeratosis", due to a previously  unknown eczema history
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: rash developed on friday 10/18 on upper body
Age: 78.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Biopsy, Erythema, Laboratory test, Lymphadenopathy, Pain
Clinical narrative: PATIENT STATED  WITHIN 24 HRS EXPERIENCED SWELLING AND PAIN.  IN 72 HRS SUBSIDED  FOR HER HUSBAND BUT THE WIFE(ADVERSE EVENT) , SWELLING PERSISTED. ON 10/11/19, "RED SPLOTCHES ABOUT QUATER SIZEAPPEARED ON LEFT ARM, PAIN INCREASED, LYMP NODES SWOLLEN ON LEFT ARE AS WELL AS JAW AND FACE".
Age: 78.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Swelling
Clinical narrative: PATIENT STATED  WITHIN 24 HRS EXPERIENCED SWELLING AND PAIN.  IN 72 HRS SUBSIDED  FOR HER HUSBAND BUT THE WIFE(ADVERSE EVENT) , SWELLING PERSISTED. ON 10/11/19, "RED SPLOTCHES ABOUT QUATER SIZEAPPEARED ON LEFT ARM, PAIN INCREASED, LYMP NODES SWOLLEN ON LEFT ARE AS WELL AS JAW AND FACE".
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Injection site swelling
Clinical narrative: patients arm started swelling at the injection site about a minute after administration, redness started spreading to neck and face. had no difficulty talking or breathing.  did not want an epipen, was given 50mg Benadryl  which she had taken before with no problems. was monitored every 10 minutes for 30 minutes.  redness in neck and face almost disappeared but arm was still a bit swollen at the injection site.
Age: 9.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Hot to touch, hard swelling around injection site, approximately 4? in diameter.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: injection site size of lemon warm to touch
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Lethargy, Nausea
Clinical narrative: High fever of 103.8 F experienced.  Injection site became raised, red, swollen, and painful (area measured 11cm X 6.5cm).  Child was lethargic and nauseated.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: High fever of 103.8 F experienced.  Injection site became raised, red, swollen, and painful (area measured 11cm X 6.5cm).  Child was lethargic and nauseated.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Injection site reaction, Injection site swelling, Rash
Clinical narrative: Patient had his left leg get very swollen and red . Seen at Urgent care on 10/19/19 and diagnosed with cellulitis and given keflex and zyrtec. I saw him in the office on  10/21/19 and the rash had resolved.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Patient has redness on the entire upper arm area around vaccination site that has last for over 11 days. No soreness or itchiness was reported.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Urticaria
Clinical narrative: mild hives after 2 days of receiving flu shot -- mostly on extremities, some on torso, not full body
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient called back in the evening of the same day. Reported swelling and redness in left are, where vaccine was give.  Patient advised to take benadryl, famotidine, and ibuprofen OTC, and to seek medical attention as soon as possible. Swelling continued into the next day; moved from upper arm to lower arm according to patient
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed a mild case of Shingles two to three days after vaccination
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia, Rash
Clinical narrative: Patient reported initial tingling in hands and feet that she could "feel" the vaccine being injected. hours later she started developing a rash that progressed across her chest and neck over the past 48 hours. denies any other symptoms. Consulted with Dr. from PCP's office and instructed patient to take Benadryl tonight. if life-threatening symptoms develop, report to Emergency room, if rash present - schedule appointment with the office.
Age: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: No adverse event, the vaccine is indicated for people 18 Y/O and up.  This should not have been administered as the patient is only 15 years old.  We did follow up with the patient and thus far she has had no negative reactions outside of site soreness.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site irritation, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, irritation, lump at injection site persisting a week after injection. moderate itching. Patient had been taking tylenol and using hot packs. Suggested using cold packs and adding diphenhydramine for itch.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling cold, Hyperaesthesia, Hypokinesia, Skin warm
Clinical narrative: (not sure of the variety of the flu vaccine, it is whatever the 2019 shot is).  Can't move arm, fever, chills, hives, swelling.  Arm is extremely sensitive to touch.  Hives are red and hot to the touch.  This is the end of the third day and it has not let up although I am able to move my arm a bit more and I don't feel as flush.  Taking ibuprofen and antihistamine.  Did an internet search and this is not uncommon but entirely unacceptable.  I feel I have lost 3 days so far, how long before I get my life back?   I have never had any adverse reaction to any medication or inoculation previously.  This is unbelievably bad... to go from healthy to inability to function because of a preventive shot?
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling, Urticaria
Clinical narrative: (not sure of the variety of the flu vaccine, it is whatever the 2019 shot is).  Can't move arm, fever, chills, hives, swelling.  Arm is extremely sensitive to touch.  Hives are red and hot to the touch.  This is the end of the third day and it has not let up although I am able to move my arm a bit more and I don't feel as flush.  Taking ibuprofen and antihistamine.  Did an internet search and this is not uncommon but entirely unacceptable.  I feel I have lost 3 days so far, how long before I get my life back?   I have never had any adverse reaction to any medication or inoculation previously.  This is unbelievably bad... to go from healthy to inability to function because of a preventive shot?
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Headache, Hypotension, Laboratory test normal, Scan normal
Clinical narrative: PT STATES THAT SHE HAD SEVERE SYNCOPE, HEADACHE AND HYPOTENSION.  PT WENT TO THE HOSPITAL EMERGENCY ROOM.  PT UNDERWENT SCANS, BLOOD TESTS AND OBSERVATION.  ALL TESTES CAME BACK NORMAL.  AFTER A FEW HOURS PT WAS RELEASED WITH NO FOLLOW UP NEEDED.  PT CAME TODAY TO TELL ME ABOUT THE PROBLEM.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: PT STATES THAT SHE HAD SEVERE SYNCOPE, HEADACHE AND HYPOTENSION.  PT WENT TO THE HOSPITAL EMERGENCY ROOM.  PT UNDERWENT SCANS, BLOOD TESTS AND OBSERVATION.  ALL TESTES CAME BACK NORMAL.  AFTER A FEW HOURS PT WAS RELEASED WITH NO FOLLOW UP NEEDED.  PT CAME TODAY TO TELL ME ABOUT THE PROBLEM.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient was given both immunization on right arm below usual injection site at 10 am. Pt returned to pharmacy later with a red, swollen arm that was warm to touch. Pt stated that her arm itched and was slightly painful. Pt was seen at urgent care and in ER. From photos from pt, the swelling extended down her right arm and hand. Returned to pharmacy a couple days later with signs of improvement/recovery.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chromaturia, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Pain, redness, swelling in arm injection site swelling in hands, feet & ankles  Red rash on legs, severe headache Severe dizziness (Fell in bathroom)  Weakness in knees (I have arthritis) Diarrhea, Dark urine, loss of appetite Lack of energy. Lasted four days. Rash lasted one week.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Headache, Injection site abscess, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling in arm injection site swelling in hands, feet & ankles  Red rash on legs, severe headache Severe dizziness (Fell in bathroom)  Weakness in knees (I have arthritis) Diarrhea, Dark urine, loss of appetite Lack of energy. Lasted four days. Rash lasted one week.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Muscular weakness, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Pain, redness, swelling in arm injection site swelling in hands, feet & ankles  Red rash on legs, severe headache Severe dizziness (Fell in bathroom)  Weakness in knees (I have arthritis) Diarrhea, Dark urine, loss of appetite Lack of energy. Lasted four days. Rash lasted one week.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Cyanosis, Dyspnoea, Rash macular
Clinical narrative: A few minutes after being given vaccine, patient's face turned blotchy and she stated that she couldn't breathe, her lips turned blue. An Epipen was administered. Her color then returned to normal as well as her breathing.
Age: 73.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Arm was red and warm down to elbow
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Cough, Dry eye, Dysphagia
Clinical narrative: Soar throat - Hard time swallowing. Like having strep throat. Aching Body - All my joints hurt very bad. No Energy at all - Aching all over Nausea, Felt warm Weak, Eyes blurry & DRY Coughing felt Like having the FLU Full Blown this was 1st time for the high dose - made me very sick
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Influenza like illness, Malaise, Nausea, Oropharyngeal pain
Clinical narrative: Soar throat - Hard time swallowing. Like having strep throat. Aching Body - All my joints hurt very bad. No Energy at all - Aching all over Nausea, Felt warm Weak, Eyes blurry & DRY Coughing felt Like having the FLU Full Blown this was 1st time for the high dose - made me very sick
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Vision blurred
Clinical narrative: Soar throat - Hard time swallowing. Like having strep throat. Aching Body - All my joints hurt very bad. No Energy at all - Aching all over Nausea, Felt warm Weak, Eyes blurry & DRY Coughing felt Like having the FLU Full Blown this was 1st time for the high dose - made me very sick
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blood test, Chest discomfort, Dizziness, Heart rate increased
Clinical narrative: Fever 101.5 Same Night as shot (Expected Fever) next day=Rapid heart, weak, chest discomfort Lightheaded. Lasted til Emergency Room 9-26-19 came back 9-28-19
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever 101.5 Same Night as shot (Expected Fever) next day=Rapid heart, weak, chest discomfort Lightheaded. Lasted til Emergency Room 9-26-19 came back 9-28-19
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Lip pruritus, Lip swelling
Clinical narrative: Student rec'd the influenza vaccine as listed in #17. Approximately 30 min later, she started to develop swelling and itching in the lower lip. There were no other reported symptoms or observed physical signs at the time of her examination in the Urgent Care. She was given Cetirizine 10 mg  and Ranitidine 300 mg orally and observed. She had no progression of symptoms or new physical exam findings and was subsequently discharged after observation for an hour.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Local reaction
Clinical narrative: localized reaction to inj. site
Age: 78.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in 10/4/19 along w/ her husband for a yearly fLu shot. All immunization protocols were followed by pharmacist - patient was fine when she left. Sat afternoon patient came in to show me her arm where shot was given - it was ReD, Warm to touch (per patient) a bit swollen and the rash radiated from injection site down past her elbow. patient stated she had applied ice to the area to minimize the reaction. She was going to pick up some Benadry and try a low dose of Ibuprofen to calm the adverse reaction. I instructed her to check back in with me Monday to see how she feels and to Assess the reaction. (1) Spoke to patient on 10/10/19 (finally heard back) and she said reaction has calMeD Down - barely noticeable in (L) arM and she is feeling just fine.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, hot, painful arm at injection site that started 3-4 hrs after administration and continued for 3-4 days
Age: 77.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site pruritus
Clinical narrative: -itching, internal x 1 week after injection on injection site/lateral deltoid of right arm -no hives, no rash, no sign of inflammation
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: R. arm became red, swollen, warm to touch. Seen at doctors office
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Skin discolouration, Skin warm, Swelling
Clinical narrative: Vaccine, Fluzone HD, received 10-10-19 at Pharmacy. Customer came back to store on 10-13-19 ask Pharmacist to look at arm. Left arm very bruise (red/purple-about 3x3 inch surface) abt 6 inches down from shoulder. States it was hot & swollen on 10/11/19 until iced.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site ulcer
Clinical narrative: Swelling and redness, pain at site initially started next day (10/3), today small ulceration at site, today (10/21) symptoms resolved but small crater at site, still recovering
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia, Pain, Swelling
Clinical narrative: pt came to report in person that the flu shot she got on 9/6/19 was giving her a lots of reactions that she'd never had before. She complained of muscle ache of the whole body, more on the upper thigh, legs, painful + swelling on other parts of body + chills. She only took Advil due to liver problem. She did not want to disclose other meds.
Age: 60.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient got vaccinated with the flu vaccine on 9/9/19. She states that her right arm where she got the shot has been very painful ever since.
Age: 64.0
Sex: F
Vaccine: FLU4, HEPA, VARZOS
Symptoms: Syncope
Clinical narrative: Patient had syncope after recieving vaccine
Age: 14.0
Sex: F
Vaccine: FLU4, HEPA, HPV4
Symptoms: Presyncope
Clinical narrative: vasovagal reaction to HPV vaccine (#2)
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Pyrexia, Rash erythematous, Skin warm, Tenderness
Clinical narrative: The night of the immunizations patient reported having Fever, Shivers, and a red rash at and below the injection site. The rash was warm and tender and approximately 4 x 2 inches. Same symptoms occured Sunday (the next night)
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Rash
Clinical narrative: Rash on arm below injection site approximately 3" wide x 6" long! Patient sought medical attention and was prescribed Bactrim DS, Prednisone, Zyrtec, and Hydroxyzine. Patient also complains of having flu like symptoms.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Pyrexia
Clinical narrative: HPV (Gardisil) and FLu vaccines given 9/19/19. Fever to 102 degrees over next 24 hours - 36 hours. Had resolved by the morning of Saturday 9/21. (It was her 2nd Gardisil, and she receives flu vaccines yearly)
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Disorientation
Clinical narrative: patient states he was very disoriented after having vaccine
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness postural, Flushing, Malaise, Nausea
Clinical narrative: Patient reports standing up and feeling extremely dizzy, sick to stomach, flushed. That evening she fell asleep really early and decided the next morning not to get the second shot. She still felt unwell the next morning but felt better by mid day and decided not to call physician.
Age: 2.92
Sex: F
Vaccine: FLU4
Symptoms: Swelling face, Urticaria
Clinical narrative: 3 DAYS AFTER RECEIVING HER FLU VACCINE THE PATIENT DEVELOPED BODY WIDE HIVE AND FACIAL SWELLING. NO LIP OR TONGUE SWELLING. NO COUGH OR RESPIRATORY DISTRESS. NO OTHER IDENTIFIABLE CAUSE FOR THESE SYMPTOMS. MOTHER OF PATIENT GAVE ONE DOSE OF ORAL BENADRYL WHICH RELIEVED SYMPTOMS. SYMPTOMS DID NOT RETURN.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling to both vaccine sites. no fever, no pus. OTC Benadryl and warm compess.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Loss of personal independence in daily activities, Pain, Paraesthesia
Clinical narrative: Immediately felt pain + tingling. After 2 weeks still feels pain, cannot lift heavy things. But it is getting better, not debilitating pain, just bothersome.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Pt woke up the day after the vaccination and had hives on her arms and face. She went to her medical doctor where they prescribed her a prednisone taper, daily cetirizine and an antibiotic because she had scratched some open. She did not call us until today, 10/21/19. Documented in her profile her allergic reaction to the specific vaccine received.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site swelling, Injection site erythema, Injection site pruritus
Clinical narrative: red & a little swollen & itchy. has spread from the site of administration
Age: 14.0
Sex: F
Vaccine: FLUC4, HPV4
Symptoms: Syncope
Clinical narrative: Pt had syncope after administration of HPV vaccine. Laid pt back on table, applied ice pack to back of neck. Provider @ table side with RN + pt. Kept pt for 20 minutes after spell + she left the clinic without incident.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash macular
Clinical narrative: red itchy ring, blotchy, arm swollen
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus
Clinical narrative: Severe itching and Burning on arms, back of Hands, neck and face. rubbed off eye lashes and eye brows has gone on for months up to today I have used all kinds of lotions to stop this but I can't.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Feeling abnormal, Nausea, Scan normal, Seizure
Clinical narrative: Roughly 10 minutes after the injection, the patient stated that she felt funny. We had her sit on the bench while we brought her a cup of water. She stated she felt dizzy and nauseous. We provided her with a small garbage can while standing over her. She had a seizure, we held her so she wouldn't slump and fall. Another associate in the pharmacy called 911 so the patient was not left unattended. Patient again stated she felt dizzy, knew the name of the pharmacist, but did not recall having the seizure (shaking, etc.). After another 5 minutes she had another seizure (each approximately 20-30 seconds). After this she desperately wanted to go to the bathroom. We escorted her to the pharmacy bathroom while waiting for the ambulance to arrive. She was able to go on her own and walk with assistance.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient experienced severe shoulder/arm pain. This led her to the emergency room on 8/16/19 where she received a prescription for Norco and Prednisone. She received another prescription for Prednisone again on 8/22/19. She approached the pharmacy around 10/12/19 to explain she was still experiencing pain. She wanted to know the process of reporting the adverse event to pharmacy as the doctors wanted to do further tests/exams which were expensive.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient experienced severe shoulder/arm pain. This led her to the emergency room on 8/16/19 where she received a prescription for Norco and Prednisone. She received another prescription for Prednisone again on 8/22/19. She approached the pharmacy around 10/12/19 to explain she was still experiencing pain. She wanted to know the process of reporting the adverse event to pharmacy as the doctors wanted to do further tests/exams which were expensive.
Age: 63.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: slight headache, slight sore throat, muscle aching, swollen lymph nodes axillary on left side left arm was injection site
Age: 63.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Lymphadenopathy, Myalgia, Oropharyngeal pain, Ultrasound scan abnormal
Clinical narrative: slight headache, slight sore throat, muscle aching, swollen lymph nodes axillary on left side left arm was injection site
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Pain
Clinical narrative: Rash on upper left arm, bicep area, approximately 8 cm x 10 cm., with a red visible raised area.  The rash started about 24 hours from the vaccine time, and went away by about 56 hours from the vaccine time.  I also had mild body aches, starting about 2 days after the vaccine, and continuing for another 2-3 days.
Age: 26.0
Sex: U
Vaccine: FLU4
Symptoms: Influenza like illness
Clinical narrative: Patient mother called pharmacy to report that her daughter as flu like symptoms from the flu shot. Mom states that she needs Tamiflu and I told her that the flu shot is inactivated and that the flu is already circulating in the community. I told her that if she is having high fever she would need to be seen by a physician to get a prescription for Tamiflu.  I told mother I would report  adverse effect.  Mother made comment that her daughter did not have insurance and cannot afford to see a doctor.  I advised to give Tylenol or Advil for fever.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Eye discharge, Ocular hyperaemia, Oropharyngeal pain, Pain
Clinical narrative: Body aches, head to foot;  Chills, trembling;  Sore throat;  Eyes red and running;  Runny nose  Please note:  I am filing this report  5 1/2 hours after receiving the injection - so the reaction is ongoing.  I have consulted the enclosure provided by pharmacy;  Not sure if the info I put in on batch number is correct -  It said : Fluzone High Dose, 2019-20 SYR.  Below that: NDC: 49281-0405-65
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea, Tremor
Clinical narrative: Body aches, head to foot;  Chills, trembling;  Sore throat;  Eyes red and running;  Runny nose  Please note:  I am filing this report  5 1/2 hours after receiving the injection - so the reaction is ongoing.  I have consulted the enclosure provided by pharmacy;  Not sure if the info I put in on batch number is correct -  It said : Fluzone High Dose, 2019-20 SYR.  Below that: NDC: 49281-0405-65
Age: 75.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Rash
Clinical narrative: Patient came in 10/21/19 with a full body rash on trunk and arms.  He said it started later the day of the immunization.  I told him to take Benadryl, cortisone on worse spots and aveeno baths to help control.  Dr. phone number did not work on Monday 10/21 to notify, but will try again.  Told pt may need medal dose pak.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Lymphadenitis, Ultrasound scan, Urine analysis
Clinical narrative: Developed right inguinal lymphadenitis starting 10/16/2019, requiring PO antibiotics. Improving, but not presently resolved. This same problem occurred in January 2018 following Influenza vaccine then. Because of the 2018 event, he did not receive Influenza vaccination for the 2018-2019 season.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received improperly stored VARIVAX; No adverse effect reported; This spontaneous report as received from a register nurse refers to a patient of unknown age and gender.  The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  The nurse reported that on 25-SEP-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number R019237 with expiration date 04-JUL-2020 or lot number S005078 with expiration date 19-FEB-2021(the nurse did not knew which lot number was administered to the patient) (dosage, route and anatomical location were not reported) for prophylaxis, which was exposed to temperature excursion of  -14°C to -10°C (-9.74°C) for an unknown time frame, because of data logger. There was no previous temperature excursion. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effects reported.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms reported; The patient received the first dose of GARDASIL quadrivalent when she was 25 years of age; This spontaneous report has been received from a medical assistant, concerning  a currently 33 years old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On an unknown date (also reported as "when she was 25 years of age"),  the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (frequency, anatomical location, lot number and expiration date were not reported) for prophylaxis.   On 15-OCT-2019, she reported that she received her first dose of  quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) when she was 25 years of age. At the reporting time (also reported as "now"), the patient that was 33 years old, would like to continued the series with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).  No adverse symptoms reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: on unspecified dates, four unspecified patients were administered an improperly stored dose of VARIVAX; No adverse effects reported; This spontaneous report was received from a vaccine coordinator referring to four unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported.  On unspecified dates, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S005084  and expiration date: 19-FEB-2019 (strength, dose, frequency and anatomical location were not provided) for prophylaxis. The administered doses of the vaccines were stored at the following  temperatures: from -14 degrees Celsius to -10 degrees Celsius (mainly at -13.6 degrees Celsius) for 5 hours and from -14 degrees Celsius to -10 degrees Celsius (mainly at -14.2 degrees Celsius) for 6 hours. The vaccines were reconstituted with Merck's sterile diluent lot # S014277 and expiration date: 31-JAN-2022, which was properly stored. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; The patient was inadvertently administered an expired dose of Rotateq; This spontaneous non valid report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On 16-OCT-2019, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R007150, expiration date on 15-OCT-2019, orally, for prophylaxis(strength, dosage and frequency were not provided) (expired product administered). No adverse effects were reported. There were no temperature excursion.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Vaccination complication
Clinical narrative: Reaction to shingles vaccine; This spontaneous report was received from a consumer regarding an elderly female patient of unknown age. The patient's medical history and concomitant medications were not reported. Her concurrent conditions included moderate to severe rheumatoid arthritis.      On an unknown date, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) as prophylaxis (Strength, dose, route of administration, lot # and expirationd ate were not reported). Other suspect therapies included adalimumab(HUMIRA) citrate free, administered via subcutaneous for moderate to severe rheumatoid arthritis (Strength, dose, frequency, lot # and expiration date were not reported).    On an unknown date, the patient experienced a reaction to shingles vaccine (vaccination complication). The action takwen with suspect therapies was not reported. The outcome of vaccination complication was reported as recovered on an unspecified date.   The reporter considered vaccination complication to be related to Zoster Vaccine Live(ZOSTAVAX) and to be reasonable possible related to adalimumab(HUMIRA).
Sex: U
Vaccine: FLU4
Symptoms: Skin reaction
Clinical narrative: Severe topical reaction; This case was reported by a pharmacist via sales rep and described the occurrence of skin reaction in an unspecified number of  patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent .5 ml. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced skin reaction. On an unknown date, the outcome of the skin reaction was unknown.   It was unknown if the reporter considered the skin reaction to be related to FluLaval Quadrivalent.  Additional details were provided as follows: This case was reported by the reporter for his or her prisons employees. The age at vaccination was not reported. The reporter stated that the patients had severe topical reactions to FluLaval. This is 1 of the 2 cases reported by the same reporter.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Pain in extremity
Clinical narrative: Back pain; Radiating leg pain; This case was reported by a nurse via call center representative and described the occurrence of back pain in a 58-year-old male patient who received Flu Seasonal QIV (FluLaval Tetra 2019-2020 season) (batch number 97S5T, expiry date 30th June 2020) for prophylaxis.   On 8th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 9th October 2019, 1 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced back pain and leg pain. On an unknown date, the outcome of the back pain and leg pain were recovering/resolving.   It was unknown if the reporter considered the back pain and leg pain to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The reporter stated that the patient after vaccination woke up with low back pain with radiating leg pain. The reporter consented to follow up. This case has been linked with cases US2019186959, US2019186960, US2019187944, reported by the same reporter.
Sex: M
Vaccine: TDAP
Symptoms: Feeling abnormal
Clinical narrative: Head in a fog; This case was reported by a nurse via call center representative and described the occurrence of foggy feeling in head in a 49-year-old male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, several years after receiving Tdap Vaccine, the patient experienced foggy feeling in head. On an unknown date, the outcome of the foggy feeling in head was unknown.   It was unknown if the reporter considered the foggy feeling in head to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient patient received an unknown brand of Tdap or Td vaccine over ten years ago and felt like his head was in a fog. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: difficult raising left arm; fever; headache; body aches; flu like symptoms; inappropriate schedule of vaccine; pain at injection site; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th March 2019).   On 16th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, movement disorder, fever, headache, general body pain, influenza-like symptoms and inappropriate schedule of vaccine administered. On 17th October 2019, the outcome of the fever, headache, general body pain and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site swelling and movement disorder were not recovered/not resolved and the outcome of the inappropriate schedule of vaccine administered was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, movement disorder, fever, headache, general body pain and influenza-like symptoms to be related to Shingrix.  Additional details were received as follows: The patient was suppose to get her second injection on or before 8th September 2019, but was late, which led to lengthening of vaccination schedule. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up. This case was linked to case US2019044314, reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Movement disorder, Pain, Pyrexia
Clinical narrative: difficult raising left arm; fever; headache; body aches; flu like symptoms; inappropriate schedule of vaccine; pain at injection site; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th March 2019).   On 16th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, movement disorder, fever, headache, general body pain, influenza-like symptoms and inappropriate schedule of vaccine administered. On 17th October 2019, the outcome of the fever, headache, general body pain and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site swelling and movement disorder were not recovered/not resolved and the outcome of the inappropriate schedule of vaccine administered was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, movement disorder, fever, headache, general body pain and influenza-like symptoms to be related to Shingrix.  Additional details were received as follows: The patient was suppose to get her second injection on or before 8th September 2019, but was late, which led to lengthening of vaccination schedule. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up. This case was linked to case US2019044314, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: felt under the weather; This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient felt under the weather for one month after her first dose of Shingrix. The reporter stated that the patient does not want the second dose. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; rash; This case was reported by a physician via call center representative and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2019, the patient received the 1st dose of Shingrix. On 11th October 2019, 6 days after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The rash was on the face, which was believed to be shingles. The patient was seen by the physician this week and emergency room visit was required. This case had been linked to the case US2019188976, reported by the same reporter.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Patient had loss of consciousness for about 30 seconds at time of injection. Patient had history of seizures as child, however, had no active treatment or history in 5+ years. Mother had concerns due to past medical history. Patient taken to emergency room. Per patient's guardian ER confirmed vasovagal response, no seizure activity.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo vaccine administered too early; minimum age interval not met.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reported an extremely sore arm unable to lift it above their head. Patient reported taking tylenol and naproxen for the pain as well as massaging the affected area.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Joint range of motion decreased, Muscular weakness, Myalgia, Paraesthesia
Clinical narrative: about 4 hours after getting the flu shot, noticed pain to deltoid area that has progressed over the last 3.5 wks with increased pain, feeling numbness to the forearm and ulnar side of the hand, with tingling to proximal L forearm and overall decreased ROM to the L shoulder; some weakness to LUE
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb
Clinical narrative: about 4 hours after getting the flu shot, noticed pain to deltoid area that has progressed over the last 3.5 wks with increased pain, feeling numbness to the forearm and ulnar side of the hand, with tingling to proximal L forearm and overall decreased ROM to the L shoulder; some weakness to LUE
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Myalgia, Tremor
Clinical narrative: Similar to first dose.  Severe flu like symptoms.  Head ache almost immediately, significant muscle ache within a couple of hours, chills and severe shaking.  Acetaminophen and iburprofen reduced symptoms.  Not reported although present after first vaccination:  insominia.  Frankly, I could not imagine the impact of similar side effects on my 86 year old mother.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea
Clinical narrative: Mom called on 10/21 and said that the patient reported diarrhea and nausea following receiving the vaccine.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at or around the spot that the vaccine would have been given in the left thigh
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: SORE FROM THE DATE OF INJECTION BUT DEVELOPED HOT RED TENDER SWELLING 2X2 INCHES IN INJECTION AREA WITH TENDER LYMPH NODE UNDER RIGHT AXILLA
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Hives
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Mom called on 10/21 to report patient experienced a 2inx3in welt on her arm near the injection site. The top of the welt was the injection site and it traveled down her arm towards her elbow.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Heart rate increased, Pain, Psychomotor hyperactivity
Clinical narrative: Rapid heart beat and hyper feeling, fever chills and every single part of body hurt, severe head pain that has still not responded to Advil or tylenol
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Rapid heart beat and hyper feeling, fever chills and every single part of body hurt, severe head pain that has still not responded to Advil or tylenol
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Injection site discomfort, Injection site swelling, Oropharyngeal pain, Pain
Clinical narrative: Within an hour experienced swelling and discomfort at injection site. Within 4 hours left arm became extremely swollen and painful to move or touch. Within 12 hours left arm markedly swollen from shoulder to elbow, measuring 1.5 inches larger than right arm. In addition developed sore throat, cough and sinus congestion. Swelling resolving after 72 hours.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Sinus congestion
Clinical narrative: Within an hour experienced swelling and discomfort at injection site. Within 4 hours left arm became extremely swollen and painful to move or touch. Within 12 hours left arm markedly swollen from shoulder to elbow, measuring 1.5 inches larger than right arm. In addition developed sore throat, cough and sinus congestion. Swelling resolving after 72 hours.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient experienced left arm pain after receiving TDaP vaccine.  Pain began shortly after administration.  At the time of follow up visit on 10/1/19, patient reported improvement of about 10 percent.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling
Clinical narrative: Severe swelling at injection site for several weeks.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Fatigue, Haematochezia
Clinical narrative: Infant became more tired than usual evening after vaccines, then at 5 AM the day after vaccines, had blood in stool.   By 9 AM the day after vaccines, had normal stool, was feeding well, no pain or fever reported.   Then had 3 more stools with blood during day.   Ordered U/S to rule out, intussusception, since infant didn't have any more blood in stool after that point and was well, family did not go for U/S.  Remained well with no blood in stool the next few days.