chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous
Clinical narrative: 1/17/19 - chills/shivering - fever 101.3, pain and swelling at site of injection - upper left arm muscle. Went to ER. 1/18/19 - pain in chest near left arm. 1/20 extreme rash and redness with drainage under chin forming crystals on skin if not covered w/gauze. The rash extended from under chin (with swelling) to right ear covering most of chest. Necessary to cover all of effected area w/gauze and secure as best I could w/1 hand. top of left hand and wrist also had severe rash; covering needed there also. Right arm had several spots at inside of elbow, 3 to be exact which also had severe red rash and coverage necessary. 1 small spot above L. eyebrow formed crystal and redness but did not need covering. 3 red spots on stomach did not drain - no covering needed. The redness on the chest was so bright red it resembled a piece of fresh steak being put on the grill. Took pictures to verify and remember for years to come. Blood work at the Emergency Room proved all O.K. The Echo of the heart and Stress test were fine, in fact, the cardiologist assured me I have a strong heart. They never did get to see the "red rash". My granddaughter has had the shingles 3 times on her face and my son has had them once on his face also, so this is what gave me the idea I needed protection. Last Spring I saw an interview with a doctor on TV news regarding the SHINGRIX shots - prompting me to take action. I received shot #1 on 7/17/18 and could not find the second shot until 1/17/19 - exactly 6 months later. I was confined to my home for 2 weeks except for the 3 doctor visits. Have only been out twice since then. No insurance coverage on these vaccines. My cost $332.14 total.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Hyperhidrosis, Pain in extremity, Peripheral coldness, Pruritus
Clinical narrative: 1/17/19 - chills/shivering - fever 101.3, pain and swelling at site of injection - upper left arm muscle. Went to ER. 1/18/19 - pain in chest near left arm. 1/20 extreme rash and redness with drainage under chin forming crystals on skin if not covered w/gauze. The rash extended from under chin (with swelling) to right ear covering most of chest. Necessary to cover all of effected area w/gauze and secure as best I could w/1 hand. top of left hand and wrist also had severe rash; covering needed there also. Right arm had several spots at inside of elbow, 3 to be exact which also had severe red rash and coverage necessary. 1 small spot above L. eyebrow formed crystal and redness but did not need covering. 3 red spots on stomach did not drain - no covering needed. The redness on the chest was so bright red it resembled a piece of fresh steak being put on the grill. Took pictures to verify and remember for years to come. Blood work at the Emergency Room proved all O.K. The Echo of the heart and Stress test were fine, in fact, the cardiologist assured me I have a strong heart. They never did get to see the "red rash". My granddaughter has had the shingles 3 times on her face and my son has had them once on his face also, so this is what gave me the idea I needed protection. Last Spring I saw an interview with a doctor on TV news regarding the SHINGRIX shots - prompting me to take action. I received shot #1 on 7/17/18 and could not find the second shot until 1/17/19 - exactly 6 months later. I was confined to my home for 2 weeks except for the 3 doctor visits. Have only been out twice since then. No insurance coverage on these vaccines. My cost $332.14 total.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Skin disorder, Skin exfoliation, Skin warm
Clinical narrative: 1/17/19 - chills/shivering - fever 101.3, pain and swelling at site of injection - upper left arm muscle. Went to ER. 1/18/19 - pain in chest near left arm. 1/20 extreme rash and redness with drainage under chin forming crystals on skin if not covered w/gauze. The rash extended from under chin (with swelling) to right ear covering most of chest. Necessary to cover all of effected area w/gauze and secure as best I could w/1 hand. top of left hand and wrist also had severe rash; covering needed there also. Right arm had several spots at inside of elbow, 3 to be exact which also had severe red rash and coverage necessary. 1 small spot above L. eyebrow formed crystal and redness but did not need covering. 3 red spots on stomach did not drain - no covering needed. The redness on the chest was so bright red it resembled a piece of fresh steak being put on the grill. Took pictures to verify and remember for years to come. Blood work at the Emergency Room proved all O.K. The Echo of the heart and Stress test were fine, in fact, the cardiologist assured me I have a strong heart. They never did get to see the "red rash". My granddaughter has had the shingles 3 times on her face and my son has had them once on his face also, so this is what gave me the idea I needed protection. Last Spring I saw an interview with a doctor on TV news regarding the SHINGRIX shots - prompting me to take action. I received shot #1 on 7/17/18 and could not find the second shot until 1/17/19 - exactly 6 months later. I was confined to my home for 2 weeks except for the 3 doctor visits. Have only been out twice since then. No insurance coverage on these vaccines. My cost $332.14 total.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin weeping, Tremor, Vaccination complication
Clinical narrative: 1/17/19 - chills/shivering - fever 101.3, pain and swelling at site of injection - upper left arm muscle. Went to ER. 1/18/19 - pain in chest near left arm. 1/20 extreme rash and redness with drainage under chin forming crystals on skin if not covered w/gauze. The rash extended from under chin (with swelling) to right ear covering most of chest. Necessary to cover all of effected area w/gauze and secure as best I could w/1 hand. top of left hand and wrist also had severe rash; covering needed there also. Right arm had several spots at inside of elbow, 3 to be exact which also had severe red rash and coverage necessary. 1 small spot above L. eyebrow formed crystal and redness but did not need covering. 3 red spots on stomach did not drain - no covering needed. The redness on the chest was so bright red it resembled a piece of fresh steak being put on the grill. Took pictures to verify and remember for years to come. Blood work at the Emergency Room proved all O.K. The Echo of the heart and Stress test were fine, in fact, the cardiologist assured me I have a strong heart. They never did get to see the "red rash". My granddaughter has had the shingles 3 times on her face and my son has had them once on his face also, so this is what gave me the idea I needed protection. Last Spring I saw an interview with a doctor on TV news regarding the SHINGRIX shots - prompting me to take action. I received shot #1 on 7/17/18 and could not find the second shot until 1/17/19 - exactly 6 months later. I was confined to my home for 2 weeks except for the 3 doctor visits. Have only been out twice since then. No insurance coverage on these vaccines. My cost $332.14 total.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Cardiac disorder, Cough, Echocardiogram, Fatigue
Clinical narrative: Pain and paralysis right arm for 3 mos - still. Cough from time of injection 4 mos - still. New Cardio and Pulmonary issues never before. 3 hernias from cough, repaired in July 2018. Still no energy, a lot of fatigue. Body aches all over! Hand tremors R/hand. Pt reports still the same complaints of feeling fatigued. He is followed by Pulm and Cardio. He reports he had an ECHO and was told there's no changes. Pt maintains it was the Pneumonia shot that got him so sick last year. He wants to get the records of the vaccine, i.e., Lot# exp. date and manufacturer he needs it this week so he can give to the FDA, CD etc. Pt informed of ROI process. Voiced understanding. He said he tried to ask Medical Records and was told they couldn't locate the exact info. Chart reviewed, pt had the PNEUMOVAX 23 on 9/7/17 during his visit with PCP, pt was due to be given for Pneumonia shot per reminder and LPN gave it pt per requirement.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Hernia, Hernia repair, Lung disorder, Monoplegia, Pain
Clinical narrative: Pain and paralysis right arm for 3 mos - still. Cough from time of injection 4 mos - still. New Cardio and Pulmonary issues never before. 3 hernias from cough, repaired in July 2018. Still no energy, a lot of fatigue. Body aches all over! Hand tremors R/hand. Pt reports still the same complaints of feeling fatigued. He is followed by Pulm and Cardio. He reports he had an ECHO and was told there's no changes. Pt maintains it was the Pneumonia shot that got him so sick last year. He wants to get the records of the vaccine, i.e., Lot# exp. date and manufacturer he needs it this week so he can give to the FDA, CD etc. Pt informed of ROI process. Voiced understanding. He said he tried to ask Medical Records and was told they couldn't locate the exact info. Chart reviewed, pt had the PNEUMOVAX 23 on 9/7/17 during his visit with PCP, pt was due to be given for Pneumonia shot per reminder and LPN gave it pt per requirement.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Tremor
Clinical narrative: Pain and paralysis right arm for 3 mos - still. Cough from time of injection 4 mos - still. New Cardio and Pulmonary issues never before. 3 hernias from cough, repaired in July 2018. Still no energy, a lot of fatigue. Body aches all over! Hand tremors R/hand. Pt reports still the same complaints of feeling fatigued. He is followed by Pulm and Cardio. He reports he had an ECHO and was told there's no changes. Pt maintains it was the Pneumonia shot that got him so sick last year. He wants to get the records of the vaccine, i.e., Lot# exp. date and manufacturer he needs it this week so he can give to the FDA, CD etc. Pt informed of ROI process. Voiced understanding. He said he tried to ask Medical Records and was told they couldn't locate the exact info. Chart reviewed, pt had the PNEUMOVAX 23 on 9/7/17 during his visit with PCP, pt was due to be given for Pneumonia shot per reminder and LPN gave it pt per requirement.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Otitis media acute, Rash erythematous, Streptococcus test negative
Clinical narrative: Patient developed an exanthematous rash 2 weeks after receiving MMR vaccine. History complicated by the fact that he was 7 days into Amoxicillin dosing for AOM as well. Discussed symptomatic treatment with TYLENOL and MOTRIN. Encourage fluids and rest. F/U if symptoms increase or prn.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness postural, Fatigue, Gait disturbance, Walking aid user
Clinical narrative: Dizziness upon getting out of bed. Came in waves during tiredness during day, very unsteady when walking. Used a cane for steadiness. Lasted for 4 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea, Diarrhoea haemorrhagic, Loss of consciousness
Clinical narrative: Fever, unspecified fever cause. Diarrhea, unspecified type. Shivering, Myalgia. Adverse effect of vaccine, initial encounter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Vaccination complication
Clinical narrative: Fever, unspecified fever cause. Diarrhea, unspecified type. Shivering, Myalgia. Adverse effect of vaccine, initial encounter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Fever, unspecified fever cause. Diarrhea, unspecified type. Shivering, Myalgia. Adverse effect of vaccine, initial encounter.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Fatigue, Headache, Malaise, Nervousness
Clinical narrative: She was feeling like she was going to faint/ very shaky on 2/8/19. Right thigh pain and sore arm. She had to come home from school that day and it lasted about 1.5 days. She currently has had headaches for the past few days as well as exhaustion and a general feeling of malaise.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain in extremity
Clinical narrative: She was feeling like she was going to faint/ very shaky on 2/8/19. Right thigh pain and sore arm. She had to come home from school that day and it lasted about 1.5 days. She currently has had headaches for the past few days as well as exhaustion and a general feeling of malaise.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Cant lift my left arms at all, its falling and it is very painful, the moment she released the vaccines my arms is so painful and feels like it was dead and cant lift at all.
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus
Clinical narrative: Pt reported have itching begin within in 1-2 hours after vaccine on 2/5/19. Notified the health department on 2/8/19 when itching did not subside. Pt reported no rash, hives, or SOB. This RN consult with Medical Director, and he advised to have pt take OTC BENADRYL. If no Sx relief, pt should contact Private MD. Pt verbalized understanding. On 2/11/19 pt called this RN and stated the itching did not stop after taking the BENADRYL and she went to see her MD. He prescribed a steroid cream, prednisone, and increased strength BENADRYL. Called patient 2/12/19 and pt reports that symptoms are still present but somewhat improved. Notified MD and instructed this RN to complete VAERS.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Hyperhidrosis, Pain, Taste disorder
Clinical narrative: ONGOING BUT SLOWLY DECLINING: SEVERE CHILLS, SWEATING, ACHES, COUGH, TASTE DISTURBANCE.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, RV1
Symptoms: Diarrhoea, Eczema
Clinical narrative: After getting vaccinated, the patient experienced diarrhea for two weeks, slept all day for about a week, and lastly and most severely, broke out into extreme eczema that covered the entire body. The patient had no allergies and no issues with any foods until after getting vaccinated. The mother had to stop breastfeeding because food allergies also developed which worsened the eczema. The eczema has not yet completely gone away and the patient is a year old.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: Severe pain in upper arm, weakness of arm. Unable to lift arm without severe pain.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Laboratory test, Urinary tract infection
Clinical narrative: Patient was screened appropriately, indicated she had no reason to think she was pregnant. Urine HCG just prior to vaccination was negative. Patient reported UTI symptoms 22 Jan 2019, routine labs drawn, which included a serum HCG (positive). Serum HCG qual and quant drawn on 30 Jan 2019: results positive and 8509.0 mIU/mL. Patient referred to OB and Regulatory Authority, is being enrolled in their Pregnancy Registry.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site swelling, Myalgia, Pain, Rash erythematous
Clinical narrative: Soreness, red rash, swelling at innoculation site. Muscle pain (flu-like) entire body for 30 hours.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site urticaria
Clinical narrative: Client developed what appeared to be a single welt or induration at site of injection immediately after vaccination. Client was monitored for 30 minutes by two nurses. No other welts or indurations developed, no respiratory signs/symptoms or angioedema. Pt was smiling and happy during observation. Advised mother of pt to get BENADRYL on way home and to monitor for difficulty breathing, facial swelling, and further cutaneous symptoms; advised to go to ED if such symptoms developed. Mom agreed to this plan. Several attempts to follow up with mom were made by this RN and a supervisor over the next two days; messages were left but were never returned.
Age: 28.0
Sex: M
Vaccine: YF
Symptoms: Pharyngeal swelling
Clinical narrative: About 20 minutes after receiving the vaccine the client reported a slight swelling sensation or change in sensation in back of the throat. Client was given EPI 0.5 cc IM. Sensation resolved within 5 minutes. Client was observed for 30 minutes after and did not have any recurrence of Sx. Did not at any time have any other swelling, rash, SOB, or other symptoms.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, MENB, MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This Morning patient was seen in our office by Dr.  Dr. ordered a Hep B ped/adol and a Hep A ped/adol vaccine, before drawing the vaccine up I questioned why the patient was going to receive pediatric vaccines since she was 18 years and 3 months old. I had asked Associate and we pulled the package inserts for both the HepB ped/adol and the Hep A ped/adol vaccines. In the package insert for the Hep B it stated that it is to be given to patient up to the age of 19 years and the Hep A ped/adol was to given up the age of 18 years. So Associate and I came to the conclusion that the patient should be receiving the Hep A adult vaccine since the package insert states up to 18 years of age. I had informed Dr. of the change and that I had T-up the order for her to sign on the Hep A adult vaccine. She said that was fine and went into her office to sign the order while I went into the patients room and administered the vaccines. After I came out of the room Dr. asked for my help because EPIC would not allow her to sign the order. I took a look at her screen and asked her to give me a second to figure out why she could not sign the order. Associate and I then double checked to make sure we read the package insert correctly and gave the health Department a call. Per Health Department Hep A ped/adol vaccine is to be given to patients up to 18 years and 11 months of age. Since the patient was 18 years and 3 months of age she should have received a pediatric dose. The Health Department did inform us that there is no harm to the patient and that when she comes back for her second Hep A dose that as long as she is in the 18 years and 11 months age range she is to receive a Hep A peds/adol vaccine. We then questioned the Hep B ped/adol vaccine and we where told by the health Department that it is to be given to patient up 19 years and 11 months of age. I will file the Red Form and I am filling out a VAERS form for the Health Department. I will also call the patient to inform her on what happened and to assure her that there is no harm to her for receiving the Hep A adult vaccine.
Age: 42.0
Sex: M
Vaccine: UNK
Symptoms: Candida test, Cough, Culture, Fungal test, Gram stain
Clinical narrative: Patient is a 42-year-old male who presents for evaluation of abdominal injection site reaction. Patient states he had injection on 10/3/18 in his proximal left upper extremity. Denies any drainage of the lesion on his left upper extremity. States that the area has not opened. Denies erythema. States that he has been sick since October, stating he has had drainage, cough, and he "can't get better". I and D performed, cultures obtained, WTD drsg BID.
Age: 42.0
Sex: M
Vaccine: UNK
Symptoms: Incisional drainage, Injection site reaction, Mycobacterium test, Skin lesion
Clinical narrative: Patient is a 42-year-old male who presents for evaluation of abdominal injection site reaction. Patient states he had injection on 10/3/18 in his proximal left upper extremity. Denies any drainage of the lesion on his left upper extremity. States that the area has not opened. Denies erythema. States that he has been sick since October, stating he has had drainage, cough, and he "can't get better". I and D performed, cultures obtained, WTD drsg BID.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Joint range of motion decreased
Clinical narrative: Edema, warmth, tenderness, to left upper deltoid area with decreased ROM. Treatment Ice, Rest, Elevation, MEDROL Dose pack. Antihistamine, Close follow-up.
Age: 29.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Injection site infection, Rash
Clinical narrative: INJECTION SITE INFECTION AS WELL AS MULTI AREA RASH.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Severe chills, Fatigue, headache, Muscle Aches, Fever.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult patient here for second dose of Hepatitis B series. Patient was given 0.5 ml of Pediatric Hepatitis B vaccine by RN. The nurse called the Immunization Program as soon as she realized the error and was instructed to give a second dose of 0.5 ml Pediatric Hepatitis B vaccine that day. If the second half of the dose could be given on the same day as the first half, the vaccine would be counted as valid. The patient was called and informed of the error, and RN vaccinated him on the same day with the second half dose. Patient did not experience any adverse reactions.
Sex: M
Vaccine: MENB
Symptoms: Contraindication to vaccination
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable male consumer of an unspecified age reported for himself that he may received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient is a leukemia patient and may have received meningococcal group b rlp2086 in the past (he doesn't remember). The patient was going to school and a breakout of meningitis had broken out at school. He wanted to know if he can get the vaccine. He was wondering if the vaccine is live or dead. He got conflicting reports from two different doctors. With patient having leukemia, agent stated that it may be an adverse event for the fact that caller may have received meningococcal group b rlp2086 in past. The outcome of event leukemia was unknown.
Age: 1.25
Sex: M
Vaccine: FLU4, HIBV, PNC13
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash developed on the morning of 02/09/19. Left thigh nickel size erythema a little swelling hard tender at vaccine site. Rash today at time of office visit.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Deafness, Hearing aid user, Tinnitus
Clinical narrative: Patient experienced tinnitus on the same day as the PREVNAR-13 vaccine was administered. She did not have this symptom earlier. In time, she also started experiencing hearing loss and is now requiring hearing aids for it.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Severe pain, swelling, warmth to injection site onset a few hours after vaccine administered. Presented to office following day. Applied ice pack and administered MOTRIN 800 mg PO.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms, fever 101.5, tired, "out of it", slight dry cough, First dose was 60 days prior. I think I MAY have been fine had I waited longer between injections and had the injection in the opposite arm from the initial injection.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Cellulitis
Clinical narrative: Patient developed lower left arm cellulitis just above her elbow on the inside of the arm. She was prescribed doxycycline Hycylate 100mg Tablets 1bid for 10 days and Prednisone 20 mg Tablets 6 day taper, 60mg days 1+2, 40 mg days 3+4 20 mg days 5+6.
Age: 27.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Discomfort, Erythema, Hyperaesthesia, Injection site discolouration, Injection site erythema
Clinical narrative: Vaccines were given 12:43 pm on 11/9/18. The next morning, after removing the band aid, the patient noticed the skin was red around the band aid. That evening (more than 24 hours after the injection),the redness had spread to surround the injection site and was about 3-4 inches long and 1.5-2 inches wide.It was warm to the touch and sensitive." Sleeping on the arm was bothersome".The next day, the reddened area was smaller in size but there was a paler halo around area and was raised.The redness and halo lasted a few more days. The entire "rash" was gone in less than 1 week.
Age: 27.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Vaccines were given 12:43 pm on 11/9/18. The next morning, after removing the band aid, the patient noticed the skin was red around the band aid. That evening (more than 24 hours after the injection),the redness had spread to surround the injection site and was about 3-4 inches long and 1.5-2 inches wide.It was warm to the touch and sensitive." Sleeping on the arm was bothersome".The next day, the reddened area was smaller in size but there was a paler halo around area and was raised.The redness and halo lasted a few more days. The entire "rash" was gone in less than 1 week.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Client noted to have continued muscle soreness at sight of injection. Sometimes the pain would get worse and she would have limited range of motion in arm. On 2/10/2019 client was unable to move arm. She called on 2/12/2019 and reported it to clinic. Client was advised to seek medical evaluation by PCP, urgent care, or emergency department.
Age: 0.92
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Rash all over body. Started 1 week and 1 day after shot.
Age: 12.0
Sex: M
Vaccine: TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Father states that family, including patient, had mildly upset stomach prior to taking vaccination. Child took first pill of 4-pill series at approximately 2040 on 2/9/19. Father states he thought he was giving child antacid but accidentally gave him laxative around one hour later. Then at approximately 2205 child vomited. Father states that child's mother claimed to see the pill in the vomit. Father states that child did not have fever, hives, or difficulty breathing, and felt better after vomiting. Father states child has had no issues since, but has not resumed taking remaining three vaccine pills.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site pain, Incorrect product formulation administered
Clinical narrative: Patient was administered 2 doses of the diluent instead of 1 dose diluent + 1 dose SHINGRIX. Reported soreness at site of administration.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant mediations and drug reactions or allergies were not provided. On 09-OCT-2017 and 19-NOV-2017, the patient was vaccinated with the first and the second GARDASIL 9 (dosage, route, lot # and expiration date were not reported) for prophylaxis. The patient would like to receive the third dose now. No adverse symptoms reported. No further information was provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of an unknown age and gender. Information about the patient's medical history, current conditions, drug allergies or reactions were not provided. On 28-JAN-2019, the patient was vaccinated with one dose of expired (recombinant human albumin (rHA)) PROQUAD for prophylaxis, lot # N020619 and expiration date 22-JAN-2019 (dose, route of administration and anatomical location were not reported). It also was reported that the sterile diluent that was used to reconstitute the PROQUAD was not expired. No adverse effects were reported in the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) in 2015 at a physician office, by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On an unknown date, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX and/or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Arm had begun swelling within 3-4 hours of administration. Also reported having a hard lump develop directly where the needle was inserted. Patient experience moderate pain in the arm (more than previously observed with a flu vaccine) that had lasted for 3 days. Patient had used TYLENOL and ice packs and this was enough to provide a slight comfort. After about 3 days patient exclaims that site became very red and warm to the touch, as well as itchy. This lasted for perhaps 3 days. After 6 days from the vaccination patient exclaims that all symptoms had subsided and has not experienced any residual pain/discomfort since.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Arm had begun swelling within 3-4 hours of administration. Also reported having a hard lump develop directly where the needle was inserted. Patient experience moderate pain in the arm (more than previously observed with a flu vaccine) that had lasted for 3 days. Patient had used TYLENOL and ice packs and this was enough to provide a slight comfort. After about 3 days patient exclaims that site became very red and warm to the touch, as well as itchy. This lasted for perhaps 3 days. After 6 days from the vaccination patient exclaims that all symptoms had subsided and has not experienced any residual pain/discomfort since.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Vaccination complication
Clinical narrative: No symptoms at or shortly after vaccine given in clinic. Patient with chills and HA at home and was taken to the ED where patient was Dx with reaction to vaccines.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flue like symptoms. Severe headache and body ache. Fever two degrees above normal temp.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hyperaesthesia, Muscle tightness, Neck pain, Paraesthesia
Clinical narrative: Headache on the L side of his head, and the L side of his neck was "tight" and sore, with a tingling sensation going down the L arm to his thumb. Those Sx have resolved with ibuprofen. On 2/3/19 he developed a non-pruritic rash on the L side of his neck, it has since spread up onto his L cheek and on the L side of his chest. Rash is not painful, but feels sensitive when touched. Not oozing.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Polymerase chain reaction positive, Rash, Varicella virus test positive
Clinical narrative: Headache on the L side of his head, and the L side of his neck was "tight" and sore, with a tingling sensation going down the L arm to his thumb. Those Sx have resolved with ibuprofen. On 2/3/19 he developed a non-pruritic rash on the L side of his neck, it has since spread up onto his L cheek and on the L side of his chest. Rash is not painful, but feels sensitive when touched. Not oozing.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles in thoracic dermatome.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Insomnia, Mobility decreased
Clinical narrative: PATIENT STATES INABILITY TO MOVE ARM AND HAVING TROUBLE SLEEPING.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site joint pain, Middle insomnia
Clinical narrative: Severe pain in right shoulder joint beginning approximately 4 hours after injection. Inability to raise right arm, abduct, or adduct secondary to the pain. Pain worse at night. Over the course of the past 5 days, pain has decreased immensely, especially with alternating ibuprofen and acetaminophen for pain control. Pain continues to wake me at night when lying on my right side or rolling over. Using heating pad at night in addition to the ibuprofen and TYLENOL.
Age: 68.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Fall
Clinical narrative: AFTER PATIENT RECEIVED SHOT FROM INTERN, PATIENT GOT UP FROM CHAIR AND THEN FELL AROUND 12:30 PM. PATIENT WAS THEN TAKEN TO SIT DOWN BY INTERN. PHARMACIST THEN ASKED IF PATIENT HAS EATEN. PATIENT DID NOT EAT OR DRINK ALL DAY. INTERN RETRIEVED SODA FOR PATIENT. PATIENT WAS ASKED TO STAY SEATED UNTIL 1 PM. PATIENT LEFT AT 12:55 PM AND SAID HE FELT FINE.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: Chills, tiredness, muscle pain, pain at injection site.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient claims redness and swelling at the injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Migraine, Ocular hyperaemia
Clinical narrative: Patient had immunization in the afternoon. That evening she started having flu-like symptoms. Then she had a migraine which she took medication for and found relief. Diarrhea started and lasted 2 weeks. Also her left eye became very red.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Glossitis, Pharyngeal swelling, Swollen tongue, Throat irritation
Clinical narrative: Itching, irritation and swelling in throat and tongue, difficulty breathing.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Limb mass, Pain, Peripheral swelling, Pruritus, Rash
Clinical narrative: Swelling of left arm, rash, itch, pain. Egg like lump in upper arm above injection site and moved down to the fold of the arm.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Pyrexia, Swelling
Clinical narrative: Patient experienced swelling and burning sensation a couple hours later after vaccination. Patient also described having a headache along with a slight fever. She stated that she didn't have this reaction with the first dose.
Age: 67.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Arthralgia, Dizziness, Limb discomfort, Pain in extremity, Rash macular
Clinical narrative: Patient received 2 immunizations, influenza in right arm and PREVNAR 13 in left arm on 2/5/19. Patient returned to pharmacy 2/12/19 stating she has had red blotches and warmth in her left arm. Interviewed patient and she told me starting 2/6/19 she had warmth and pain in her left arm which was blotchy, felt lightheaded, bilateral joint pain in wrists and ankles. Patient stated all symptoms resolved within the following day except her left arm warmth/discomfort and blotches. Pharmacy manager and myself examined left arm and observed the red blotches, no signs of infection were visible.
Age: 67.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Skin warm
Clinical narrative: Patient received 2 immunizations, influenza in right arm and PREVNAR 13 in left arm on 2/5/19. Patient returned to pharmacy 2/12/19 stating she has had red blotches and warmth in her left arm. Interviewed patient and she told me starting 2/6/19 she had warmth and pain in her left arm which was blotchy, felt lightheaded, bilateral joint pain in wrists and ankles. Patient stated all symptoms resolved within the following day except her left arm warmth/discomfort and blotches. Pharmacy manager and myself examined left arm and observed the red blotches, no signs of infection were visible.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient experienced tingling sensation on left side of body.
Age: 0.0
Sex: M
Vaccine: MMRV
Symptoms: Febrile convulsion, Pyrexia, Tachycardia
Clinical narrative: High fever, febrile seizure, tachycardia.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Hyperaesthesia, Skin warm
Clinical narrative: Area is red swollen and warm to the touch. Sensitive for patient. Has continued to get worse over the past 5 days. Did not improve with cold therapy.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Basophil count decreased, Basophil percentage decreased, Eosinophil count decreased, Eosinophil percentage decreased, Haematocrit normal
Clinical narrative: After receiving 1st GARDASIL Vaccine Shot patient suffered collapse of platelet counts 3 weeks after vaccine. She was admitted in Emergency Room near her. She was diagnosed with Acute ITP and had platelet count levels of 3K. This happened exactly 3 weeks after shot. Patient does not have any abnormal medical history and is currently being treated with steroid treatment to increase platelet levels. ER Hemotology at Hospital is treating patient.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Haemoglobin normal, Immune thrombocytopenic purpura, Lymphocyte count decreased, Lymphocyte count increased, Lymphocyte percentage decreased
Clinical narrative: After receiving 1st GARDASIL Vaccine Shot patient suffered collapse of platelet counts 3 weeks after vaccine. She was admitted in Emergency Room near her. She was diagnosed with Acute ITP and had platelet count levels of 3K. This happened exactly 3 weeks after shot. Patient does not have any abnormal medical history and is currently being treated with steroid treatment to increase platelet levels. ER Hemotology at Hospital is treating patient.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Lymphocyte percentage increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume increased
Clinical narrative: After receiving 1st GARDASIL Vaccine Shot patient suffered collapse of platelet counts 3 weeks after vaccine. She was admitted in Emergency Room near her. She was diagnosed with Acute ITP and had platelet count levels of 3K. This happened exactly 3 weeks after shot. Patient does not have any abnormal medical history and is currently being treated with steroid treatment to increase platelet levels. ER Hemotology at Hospital is treating patient.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Monocyte count decreased, Monocyte count increased, Monocyte percentage decreased, Neutrophil count increased, Neutrophil percentage decreased
Clinical narrative: After receiving 1st GARDASIL Vaccine Shot patient suffered collapse of platelet counts 3 weeks after vaccine. She was admitted in Emergency Room near her. She was diagnosed with Acute ITP and had platelet count levels of 3K. This happened exactly 3 weeks after shot. Patient does not have any abnormal medical history and is currently being treated with steroid treatment to increase platelet levels. ER Hemotology at Hospital is treating patient.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Neutrophil percentage increased, Platelet count decreased, Platelet count increased, Red blood cell count normal, Red cell distribution width normal
Clinical narrative: After receiving 1st GARDASIL Vaccine Shot patient suffered collapse of platelet counts 3 weeks after vaccine. She was admitted in Emergency Room near her. She was diagnosed with Acute ITP and had platelet count levels of 3K. This happened exactly 3 weeks after shot. Patient does not have any abnormal medical history and is currently being treated with steroid treatment to increase platelet levels. ER Hemotology at Hospital is treating patient.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Upper respiratory tract infection, White blood cell count increased
Clinical narrative: After receiving 1st GARDASIL Vaccine Shot patient suffered collapse of platelet counts 3 weeks after vaccine. She was admitted in Emergency Room near her. She was diagnosed with Acute ITP and had platelet count levels of 3K. This happened exactly 3 weeks after shot. Patient does not have any abnormal medical history and is currently being treated with steroid treatment to increase platelet levels. ER Hemotology at Hospital is treating patient.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Evening vaccine received patient began to notice swelling, redness, and pain at injection site - all three symptoms increasingly became worse through the night. Patient described color was almost purple at injection site and the pain radiated up to shoulder and down below elbow. The next morning (2/10) the patient noticed the swelling and redness had moved to the underside of her arm (underside of injection site). Monday (2/11) the swelling and redness had decreased, but the injection site remained hot to the touch. The patient stated that she took aspirin to alleviate the pain and applied a cold compress to the injection site.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe left arm pain.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Hyponatriuria, Immunology test, Pancytopenia, Parasitic test, Peripheral swelling
Clinical narrative: Developed bilateral hand swelling which persisted till mid December. Went to his primary care provider on 11-12-18 for hand swelling and 12-17-18. He was tested for RA, on 12-20 he was hospitalized c pantocytopenia, hyponaturia and rash which was dx on 12-25 as lupus.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash, Systemic lupus erythematosus, Viral test
Clinical narrative: Developed bilateral hand swelling which persisted till mid December. Went to his primary care provider on 11-12-18 for hand swelling and 12-17-18. He was tested for RA, on 12-20 he was hospitalized c pantocytopenia, hyponaturia and rash which was dx on 12-25 as lupus.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Itchiness at injection site developed the next day (1/23/19) and still itches today (2/12/19). No other signs or symptoms.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Bone pain, Pain, Pyrexia, Visual impairment
Clinical narrative: Shortly after administering the vaccine patient complained of not being able to see, having a fever and experiencing pain that travelled down to her hip bones. She was given water and waited until her husband came to pick her up. Before she left she stated feeling a little better. Recommended the patient go to the emergency room.
Age: 20.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Audiogram normal, Balance disorder, Blood folate normal, Blood follicle stimulating hormone normal, Blood iron normal
Clinical narrative: The day after I got the flu shot I started having this feeling of rocking, swaying, floating and it was constant, all throughout the day. I didn't find anything that was making it better or worse. I went to the urgent care clinic a week after I got the flu shot and the doctor prescribed meclizine and it didn't help at all. I saw my primary care doctor multiple times who order multiple blood work and everything was normal. For the first two months, I was having this feeling of imbalance continuously. I had to skip school and come back home. I only went back to take my finals. When it got worse, I went to the urgent care clinic and the PA prescribed VALIUM which helped for few hours. I have seen multiple neurologists in the past month and am doing physical therapy. I have terrible ear pain, ear popping and ringing. The dizziness hasn't gotten any better. I am taking a semester off from school because I can't concentrate/focus or do anything by myself. I have tried prednisone and valacyclovir and they haven't helped at all. One of the neurologist thinks its labyrinthitis. I am unable to walk by myself or shower by myself because I am so dizzy. Right now, it is not constant all day but it is still most times of the day. I am not sure if flu shot caused it but I know it started the day after I got the flu shot and before that I was completely healthy.
Age: 20.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood luteinising hormone normal, Blood prolactin normal, Blood test normal, Blood thyroid stimulating hormone normal, Culture urine negative
Clinical narrative: The day after I got the flu shot I started having this feeling of rocking, swaying, floating and it was constant, all throughout the day. I didn't find anything that was making it better or worse. I went to the urgent care clinic a week after I got the flu shot and the doctor prescribed meclizine and it didn't help at all. I saw my primary care doctor multiple times who order multiple blood work and everything was normal. For the first two months, I was having this feeling of imbalance continuously. I had to skip school and come back home. I only went back to take my finals. When it got worse, I went to the urgent care clinic and the PA prescribed VALIUM which helped for few hours. I have seen multiple neurologists in the past month and am doing physical therapy. I have terrible ear pain, ear popping and ringing. The dizziness hasn't gotten any better. I am taking a semester off from school because I can't concentrate/focus or do anything by myself. I have tried prednisone and valacyclovir and they haven't helped at all. One of the neurologist thinks its labyrinthitis. I am unable to walk by myself or shower by myself because I am so dizzy. Right now, it is not constant all day but it is still most times of the day. I am not sure if flu shot caused it but I know it started the day after I got the flu shot and before that I was completely healthy.
Age: 20.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Differential white blood cell count normal, Disturbance in attention, Dizziness, Double stranded DNA antibody, Ear discomfort
Clinical narrative: The day after I got the flu shot I started having this feeling of rocking, swaying, floating and it was constant, all throughout the day. I didn't find anything that was making it better or worse. I went to the urgent care clinic a week after I got the flu shot and the doctor prescribed meclizine and it didn't help at all. I saw my primary care doctor multiple times who order multiple blood work and everything was normal. For the first two months, I was having this feeling of imbalance continuously. I had to skip school and come back home. I only went back to take my finals. When it got worse, I went to the urgent care clinic and the PA prescribed VALIUM which helped for few hours. I have seen multiple neurologists in the past month and am doing physical therapy. I have terrible ear pain, ear popping and ringing. The dizziness hasn't gotten any better. I am taking a semester off from school because I can't concentrate/focus or do anything by myself. I have tried prednisone and valacyclovir and they haven't helped at all. One of the neurologist thinks its labyrinthitis. I am unable to walk by myself or shower by myself because I am so dizzy. Right now, it is not constant all day but it is still most times of the day. I am not sure if flu shot caused it but I know it started the day after I got the flu shot and before that I was completely healthy.