chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, unspecified number of patients were vaccinated with PEDVAXHIB (dose, route and frequency were not reported) which was exposed to 34 F for four months (worst case). No adverse effects were reported. No further information was provided. This case was linked to the case 1404USA006470 and 1404USA007006 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, unspecified number of patients were vaccinated with M-M-R II (dose, route and frequency were not reported) for which no recorded temperatures for four months. No adverse effects were reported. No further information was provided. This case is linked to the case 1404USA006470 and 1404USA007005 (same reporter link). Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient. On an unknown date in October 2013, the patient was vaccinated with ZOSTAVAX (dose and frequency were not reported). On an unknown date in October 2013, the patient experienced rash at the injection site. The patient sought the medical attention and called the pharmacist. The outcome of rash at the injection site was reported as recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Oropharyngeal pain, Rhinorrhoea, Throat irritation
Clinical narrative: This spontaneous report as received from a consumer refers to herself: a 69 year old female patient. Her medical history included degenerative hip. She had no drug reaction or allergies and reported no concomitant medications. On 13-MAR-2014 the patient was vaccinated with ZOSTAVAX, dose, route, site of administration, lot# not provided. On 13-MAR-2014, the patient woke up in the middle of the night and had a runny nose and scratchy, sore throat. She did not seek medical attention, was given no treatment for adverse effects and no lab diagnostic studies were performed. The symptoms were still running at the time of report and the patient's present status was reported as "not recovered". The relatedness between vaccination with ZOSTAVAX and reported adverse events was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Fatigue, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a 15 year old female patient. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose and lot# not reported). After the first dose of the vaccine, on an unknown date the patient experienced unexplained pain and fatigue. On an unknown date the patient was vaccinated with the second dose of GARDASIL (dose and lot# not reported). After the second dose, the pain and fatigue worsened to the point the patient could not attend school. At first, the family didn't suspect the vaccine. Doctors couldn't explain her reaction either. However, when the family mapped out her absences from school, the realized they started and intensified in the days after receiving the vaccine. It was reported by the reporter that "There's a big difference between correlation and causation and I understand that. But it seemed very clear at that point." The physician told the reporter that reactions to the vaccine do happen. The family filed a report with the FDA's Vaccine Adverse Event Reaction System (VAERS). The outcome of unexplained pain and fatigue was unknown. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Myalgia, Throat tightness
Clinical narrative: Had localized red hard lump at injection site that was extremely hot to the touch. Called Pediatrician, and spoke w/ nurse who said he was having local reaction and to put ice on it and give ibuprofen. Within 24hrs of this occurring, patient broke out in horrible hives on his entire body. Had to be taken to Urgent Care and attending Dr. said his throat was closing and administered a steroid shot and Benadryl. Prescription was written for steroids and Benadryl for 10 days. It took a full 10 days for patient to stop breaking out in hives. It was like the toxin from the vaccine had to work it's way through his entire body. He complained of sore muscles during this time as well.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Had localized red hard lump at injection site that was extremely hot to the touch. Called Pediatrician, and spoke w/ nurse who said he was having local reaction and to put ice on it and give ibuprofen. Within 24hrs of this occurring, patient broke out in horrible hives on his entire body. Had to be taken to Urgent Care and attending Dr. said his throat was closing and administered a steroid shot and Benadryl. Prescription was written for steroids and Benadryl for 10 days. It took a full 10 days for patient to stop breaking out in hives. It was like the toxin from the vaccine had to work it's way through his entire body. He complained of sore muscles during this time as well.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, pruritis, pain at site of vaccination, started 9 days after the vaccine. No systemic symptoms. Started 1 day ago, worse today.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site urticaria, Joint range of motion decreased, Swelling
Clinical narrative: Severe swelling, redness, decreased ROM, urticaria at injection site.
Age: 1.17
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Vomiting, White blood cell count
Clinical narrative: Fever ranging from 99.8 to 100.8. Vomited 4 times in a 24 hour time period.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Sore, small red spot at injection site that night. The following morning, the red area had tripled in size, red, itching, hot to touch, and very painful. This has lasted 4 days. It is slowly improving, but still has not resolved.
Age: 68.0
Sex: M
Vaccine: TTOX
Symptoms: Injected limb mobility decreased
Clinical narrative: Can't raise left arm out from body.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Foetal death
Clinical narrative: I was 21 weeks pregnant when I received the Flu vaccine and in less than 2 weeks later my baby was dead. I believe the flu shot was poison to my baby.
Age: 0.16
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a clinical medical assistant (CMA) refers to a 8 week old patient. On 02-APR-2014 the patient was vaccinated with expired ROTATEQ (lot # H015715, expired date 15-MAR-2014) as the first dose of ROTATEQ. No adverse effect reported. Additional information is not expected.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles vaccine given 3-30-14. Two days later the patient broke out in shingles rash on the side of his stomach. (left side)
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately 76 years old female. The patient drug reactions/allergies were reported to codeine and sulfa. On 30-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # J007210, Expiry date-20-SEP-2014, route subcutaneous and patient developed redness and swelling at the injection site, developed a bruise further down from the injection site after the redness and swelling resolved. The outcome of patient developed redness and swelling at the injection site was reported as recovered/resolved. The outcome of developed a bruise further down from the injection site was reported as not recovered/not resolved. The patient sought medical attention. No product quality complaint was involved. The causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that on 08-APR-2014 the patient was vaccinated with expired dose of ZOSTAVAX (lot number, expiration date unspecified) (dose, strength, indication route was not reported). No adverse effects reported. The outcome of received an expired dose of ZOSTAVAX is unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash, Rash erythematous, Rash pustular
Clinical narrative: This spontaneous report as received from a consumer regarding herself refers to a approximately 69 years old female patient height-5'7. The patient medical history included thyroid condition and drug reactions/allergies was reported to sulfa. It was reported that patient did not want to provide the names of concomitant medication. On 29-JAN-2013 the patient was vaccinated with ZOSTAVAX dose 1. On 04-APR-2014 the patient found rash on the right arm from armpit to elbow, rash was painful red rash accompanied by pustules. The reporter stated that she thinks injection was given in 1994 but feels this time the shingles was worse and in a different area than this episode. Investigations included labs done for thyroid (unknown date): unknown results. The events were treated by antivirals Famciclovir 500mg 1 tablet in every hours. The outcome of rash on the right arm from armpit to elbow and rash was painful red rash accompanied by pustules, shingles is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Thyroid function test
Clinical narrative: This spontaneous report as received from a consumer regarding herself refers to a approximately 69 years old female patient height-5'7. The patient medical history included thyroid condition and drug reactions/allergies was reported to sulfa. It was reported that patient did not want to provide the names of concomitant medication. On 29-JAN-2013 the patient was vaccinated with ZOSTAVAX dose 1. On 04-APR-2014 the patient found rash on the right arm from armpit to elbow, rash was painful red rash accompanied by pustules. The reporter stated that she thinks injection was given in 1994 but feels this time the shingles was worse and in a different area than this episode. Investigations included labs done for thyroid (unknown date): unknown results. The events were treated by antivirals Famciclovir 500mg 1 tablet in every hours. The outcome of rash on the right arm from armpit to elbow and rash was painful red rash accompanied by pustules, shingles is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Blood immunoglobulin M increased, Cough, Mumps, Parotitis, Pyrexia
Clinical narrative: This spontaneous report as received from an epidemiologist refers to a 3 years old male patient. On 13-MAY-2011 the patient was vaccinated with first dose of M-M-R II (route of administration, dose, lot # and expiration date not reported). On 19-FEB-2014 the patient was vaccinated with second dose of M-M-R II (injection, dose and route not reported, lot # J006954 and expiration date 07-JUN-2015). On 01-MAR-2014 the patient experienced a mild case of mumps (coughing and congestion with parotitis and low grade fever) following the second dose of M-M-R II. The patient had a blood test on 06-MAR-2014 with a positive IGM (immunoglobulin M) of 3.33 (units not provided). The patient sought medical attention by contacting with physician. The outcome of the mild case of mumps was reported as recovering. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Respiratory tract congestion
Clinical narrative: This spontaneous report as received from an epidemiologist refers to a 3 years old male patient. On 13-MAY-2011 the patient was vaccinated with first dose of M-M-R II (route of administration, dose, lot # and expiration date not reported). On 19-FEB-2014 the patient was vaccinated with second dose of M-M-R II (injection, dose and route not reported, lot # J006954 and expiration date 07-JUN-2015). On 01-MAR-2014 the patient experienced a mild case of mumps (coughing and congestion with parotitis and low grade fever) following the second dose of M-M-R II. The patient had a blood test on 06-MAR-2014 with a positive IGM (immunoglobulin M) of 3.33 (units not provided). The patient sought medical attention by contacting with physician. The outcome of the mild case of mumps was reported as recovering. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fracture, Intervertebral disc protrusion, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Patient c/o (R) side buttocks and leg pain, persistent pain. Also reports a herniated disc and pelvic bone fracture.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Spinal X-ray, X-ray of pelvis and hip
Clinical narrative: Patient c/o (R) side buttocks and leg pain, persistent pain. Also reports a herniated disc and pelvic bone fracture.
Age: 21.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Local reaction
Clinical narrative: Information has been received from a registered nurse who provided medical records regarding a 21 year old female with no known drug allergies who received her first VARIVAX on 26DEC2013. The second VARIVAX was given on 03FEB2014 in her right volar forearm subcutaneously not intradermally. She initially had burning at the site. Ice was immediately applied and the extremity was elevated. She was evaluated by the physician and given BENADRYL 25 mg and ibuprofen 400mg. She was observed for 45 minutes, given water and juice. Some redness was noted on her forearm. Hydrocortisone cream was applied. Arm was red at injection site. The patient reported some drowsiness/grogginess from the BENADRYL. She was instructed to return the following day for a re-check. 04FEB2014: Office visit (OV) for re-check found patient feeling fine. She reported her right forearm was a bit itchy the previous afternoon. The pink area on the forearm was somewhat tender. Physician noted volar surface of right forearm with mildly erythematous irregular shaped, not raised area. A registered nurse called the patient on 13FEB2014 to inform her that a varicella immune titer was recommended 6 weeks post vaccine. The patient was agreeable to the titer. She also reported that her right forearm was much improved. No soreness-felt like a scab like mark that "came from within". Some discoloration was noted. Patient was instructed to protect area from sun and use sun screen. 13MAR2014 OV for varicella titer to check immunity. Varicella Zoster virus antibody (IGG) was 2.31. Additional information is not expected. All available medical records will be provided upon request.
Age: 21.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pain, Pruritus, Somnolence
Clinical narrative: Information has been received from a registered nurse who provided medical records regarding a 21 year old female with no known drug allergies who received her first VARIVAX on 26DEC2013. The second VARIVAX was given on 03FEB2014 in her right volar forearm subcutaneously not intradermally. She initially had burning at the site. Ice was immediately applied and the extremity was elevated. She was evaluated by the physician and given BENADRYL 25 mg and ibuprofen 400mg. She was observed for 45 minutes, given water and juice. Some redness was noted on her forearm. Hydrocortisone cream was applied. Arm was red at injection site. The patient reported some drowsiness/grogginess from the BENADRYL. She was instructed to return the following day for a re-check. 04FEB2014: Office visit (OV) for re-check found patient feeling fine. She reported her right forearm was a bit itchy the previous afternoon. The pink area on the forearm was somewhat tender. Physician noted volar surface of right forearm with mildly erythematous irregular shaped, not raised area. A registered nurse called the patient on 13FEB2014 to inform her that a varicella immune titer was recommended 6 weeks post vaccine. The patient was agreeable to the titer. She also reported that her right forearm was much improved. No soreness-felt like a scab like mark that "came from within". Some discoloration was noted. Patient was instructed to protect area from sun and use sun screen. 13MAR2014 OV for varicella titer to check immunity. Varicella Zoster virus antibody (IGG) was 2.31. Additional information is not expected. All available medical records will be provided upon request.
Age: 21.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Tenderness, Varicella virus test positive
Clinical narrative: Information has been received from a registered nurse who provided medical records regarding a 21 year old female with no known drug allergies who received her first VARIVAX on 26DEC2013. The second VARIVAX was given on 03FEB2014 in her right volar forearm subcutaneously not intradermally. She initially had burning at the site. Ice was immediately applied and the extremity was elevated. She was evaluated by the physician and given BENADRYL 25 mg and ibuprofen 400mg. She was observed for 45 minutes, given water and juice. Some redness was noted on her forearm. Hydrocortisone cream was applied. Arm was red at injection site. The patient reported some drowsiness/grogginess from the BENADRYL. She was instructed to return the following day for a re-check. 04FEB2014: Office visit (OV) for re-check found patient feeling fine. She reported her right forearm was a bit itchy the previous afternoon. The pink area on the forearm was somewhat tender. Physician noted volar surface of right forearm with mildly erythematous irregular shaped, not raised area. A registered nurse called the patient on 13FEB2014 to inform her that a varicella immune titer was recommended 6 weeks post vaccine. The patient was agreeable to the titer. She also reported that her right forearm was much improved. No soreness-felt like a scab like mark that "came from within". Some discoloration was noted. Patient was instructed to protect area from sun and use sun screen. 13MAR2014 OV for varicella titer to check immunity. Varicella Zoster virus antibody (IGG) was 2.31. Additional information is not expected. All available medical records will be provided upon request.
Sex: F
Vaccine: HPV2, MNQ, HPV2, MNQ
Symptoms: Blood test normal, Borrelia test negative, Culture urine negative, Cytomegalovirus test negative, Dizziness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fatigue in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no concomitant medication. Concurrent medical conditions included allergy to guaifenesin. Concurrent vaccination included meningococcal acwy vaccine (non-GSK manufacturer) given on 4 November 2013. On 4 November 2013 the subject received 1st dose of CERVARIX (unknown route). At an unspecified time after 1st vaccination with CERVARIX, the subject experienced fatigue. On 13 January 2014 the subject received 2nd dose of CERVARIX (unknown route). At an unspecified time after 2nd vaccination with CERVARIX, the subject experienced fatigue aggravated, vertigo and headache all lasting more than 6 weeks. The subject was getting home schooled as a result. The healthcare professional considered the events were disabling. A blood test and a MRI were done. The subject was negative for mononucleosis. The subject went to a neurologist on 3 March 2014, who told her that it may be a delayed reaction to vaccination. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: HPV2, MNQ, HPV2, MNQ
Symptoms: Fatigue, Full blood count normal, Headache, Mononucleosis heterophile test negative, Red blood cell sedimentation rate normal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fatigue in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no concomitant medication. Concurrent medical conditions included allergy to guaifenesin. Concurrent vaccination included meningococcal acwy vaccine (non-GSK manufacturer) given on 4 November 2013. On 4 November 2013 the subject received 1st dose of CERVARIX (unknown route). At an unspecified time after 1st vaccination with CERVARIX, the subject experienced fatigue. On 13 January 2014 the subject received 2nd dose of CERVARIX (unknown route). At an unspecified time after 2nd vaccination with CERVARIX, the subject experienced fatigue aggravated, vertigo and headache all lasting more than 6 weeks. The subject was getting home schooled as a result. The healthcare professional considered the events were disabling. A blood test and a MRI were done. The subject was negative for mononucleosis. The subject went to a neurologist on 3 March 2014, who told her that it may be a delayed reaction to vaccination. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: HPV2, MNQ, HPV2, MNQ
Symptoms: Thyroid function test normal, Vertigo
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fatigue in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no concomitant medication. Concurrent medical conditions included allergy to guaifenesin. Concurrent vaccination included meningococcal acwy vaccine (non-GSK manufacturer) given on 4 November 2013. On 4 November 2013 the subject received 1st dose of CERVARIX (unknown route). At an unspecified time after 1st vaccination with CERVARIX, the subject experienced fatigue. On 13 January 2014 the subject received 2nd dose of CERVARIX (unknown route). At an unspecified time after 2nd vaccination with CERVARIX, the subject experienced fatigue aggravated, vertigo and headache all lasting more than 6 weeks. The subject was getting home schooled as a result. The healthcare professional considered the events were disabling. A blood test and a MRI were done. The subject was negative for mononucleosis. The subject went to a neurologist on 3 March 2014, who told her that it may be a delayed reaction to vaccination. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: HPV2, MNQ, HPV2, MNQ
Symptoms: Blood test, Condition aggravated, Fatigue, Headache, Mononucleosis heterophile test negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fatigue in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no concomitant medication. Concurrent medical conditions included allergy to guaifenesin. Concurrent vaccination included meningococcal acwy vaccine (non-GSK manufacturer) given on 4 November 2013. On 4 November 2013 the subject received 1st dose of CERVARIX (unknown route). At an unspecified time after 1st vaccination with CERVARIX, the subject experienced fatigue. On 13 January 2014 the subject received 2nd dose of CERVARIX (unknown route). At an unspecified time after 2nd vaccination with CERVARIX, the subject experienced fatigue aggravated, vertigo and headache all lasting more than 6 weeks. The subject was getting home schooled as a result. The healthcare professional considered the events were disabling. A blood test and a MRI were done. The subject was negative for mononucleosis. The subject went to a neurologist on 3 March 2014, who told her that it may be a delayed reaction to vaccination. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: HPV2, MNQ, HPV2, MNQ
Symptoms: Nuclear magnetic resonance imaging, Vertigo
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fatigue in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no concomitant medication. Concurrent medical conditions included allergy to guaifenesin. Concurrent vaccination included meningococcal acwy vaccine (non-GSK manufacturer) given on 4 November 2013. On 4 November 2013 the subject received 1st dose of CERVARIX (unknown route). At an unspecified time after 1st vaccination with CERVARIX, the subject experienced fatigue. On 13 January 2014 the subject received 2nd dose of CERVARIX (unknown route). At an unspecified time after 2nd vaccination with CERVARIX, the subject experienced fatigue aggravated, vertigo and headache all lasting more than 6 weeks. The subject was getting home schooled as a result. The healthcare professional considered the events were disabling. A blood test and a MRI were done. The subject was negative for mononucleosis. The subject went to a neurologist on 3 March 2014, who told her that it may be a delayed reaction to vaccination. At the time of reporting the outcome of the events was unspecified.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: Arm became red and swollen evening of injection. Patient reports arm sore and itchy; left upper arm with 8 cm ring of erythema and swelling, mild tenderness. Treated with cetirizine and mometasone cream.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Arm became red and swollen evening of injection. Patient reports arm sore and itchy; left upper arm with 8 cm ring of erythema and swelling, mild tenderness. Treated with cetirizine and mometasone cream.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Swelling at site of injection with a very hard knot under the skin.  Extremely tender to the touch and hot to touch.  Increased tiredness. Interfered with sleep - could not lay on that side.  Did not need medical attention.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Sleep disorder
Clinical narrative: Swelling at site of injection with a very hard knot under the skin.  Extremely tender to the touch and hot to touch.  Increased tiredness. Interfered with sleep - could not lay on that side.  Did not need medical attention.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Rash
Clinical narrative: Rash on buttocks.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC
Symptoms: Pyrexia
Clinical narrative: Fever to 104.4 about 24 hours after vaccines. Seen in ER - no labs or treatments given, recommended fever tx.
Sex: F
Vaccine: TYP, YF
Symptoms: Herpes virus infection
Clinical narrative: Initial case received from a pharmacist on 10 April 2014. A female patient, whose medical history was unknown, received a dose of YF-Vax (lot number not reported) and an oral dose of VIVOTIF (other manufacturer, lot number not reported) on 07 April 2014. Two days post-vaccination, on 09 April 2014, she experienced a relapse of herpes. Outcome was not reported. Documents held by sender: None.
Age: 16.0
Sex: M
Vaccine: YF
Symptoms: Dysphagia, Dyspnoea, Urticaria
Clinical narrative: This case was reported on 09-APR-2014 from a physician. This case involves a 16 year(s) old Male who was vaccinated with Yellow Fever Vaccine on 31 March 2014, batch UH599AA (dose, route and site of administration not reported). The patient's medical history and concomitant medications were not reported. Within 30 minutes after vaccination, the patient experienced hives, difficulty breathing and swallowing. Epinephrine was administered and breathing and swallowing improved. The patient continues to have hives. Laboratory tests were not reported. Further details were not available at the time of this report. The patient outcome was not reported. Documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Left arm stiff. Unable to lift past shoulder height without assistance. Pain on passive ROM post TDAP (x2 days).
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, malaise, chills, vertigo, headache, low-grade fever (101 F).
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Vertigo
Clinical narrative: Sore arm, malaise, chills, vertigo, headache, low-grade fever (101 F).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and pruritis MMRV1 (R) thigh.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception, Laparoscopic surgery, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: ROTATEQ oral vaccine third dose on 3/4/14. Vomiting and diagnosis of intussusception 3/30/14 (26 days later). Treated with laparoscopic reduction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling and redness at injection site, about 2 inches in diameter, hard - observed day after injection - per pt events began day of injection. Advised pt. to use cold compress off and on, and to let us know if sym. worsened. Next day affected area approximately 6 inches in diameter, blistered, swollen, hot, painful.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Swelling and redness at injection site, about 2 inches in diameter, hard - observed day after injection - per pt events began day of injection. Advised pt. to use cold compress off and on, and to let us know if sym. worsened. Next day affected area approximately 6 inches in diameter, blistered, swollen, hot, painful.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Limb discomfort, Local swelling, Muscle tightness, Pain in extremity
Clinical narrative: Swelling, pain and tightness upper arm with increased intensity on 04/13/2014. Took Advil and later Ibuprofen.  04/14/2014 Tightness radiating to neck with movement of arm.
Age: 50.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Dizziness, Feeling abnormal, Pyrexia
Clinical narrative: Fever 101.3, chills, dizzy, "out of sorts, like passing out".  Pt took Motrin at home.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Hypertension, Induration, Local swelling, Nausea
Clinical narrative: Hives/rash quarter size on upper torso, neck and arms. Hives are hard, raised, burning and itchy. Patient complains of nausea/high blood pressure/burning and swelling in arms.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives/rash quarter size on upper torso, neck and arms. Hives are hard, raised, burning and itchy. Patient complains of nausea/high blood pressure/burning and swelling in arms.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Severe abdominal cramping and severe vomiting. Started late night on 11/14/2011 and lasted until early AM 11/15/2011.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Back pain, Blood test, Cardiac monitoring, Diplopia, Echocardiogram
Clinical narrative: Severe vertigo (flipping, spinning sensations - inability to walk unassisted. Onset 11/5/13 at 10 PM, continued, with varying degrees through mid-December 2013. Visual problems - reduced field of vision, double/triple vision, blurriness, movement of words on paper onset 11/5/13. Continued through January 2014. Heavy menstrual bleeding/extended periods from November 21 through January 12 bled (heavy and red) for 31 out of 50 days. Lower back pain - onset November 30, 2013, subsided by mid to late December, but still occasionally bothers. Difficulty walking/Irregular gait - onset November 5, 2013, subsided by mid-December. Fainting/Syncope - onset January 6, daily occurrences - often 2-3 times a day - through mid-March. Still has fainting episodes but frequency is reduced with medication. Tremors - uncontrolled tremors in arms and legs. Started after fainting during first week in January; by mid-January the tremors were present throughout the day, not just after fainting.  Tremors continued until early February. Possible Autoimmune Disorder - Antiphospholipid syndrome. Orthostatic Intolerance - ongoing, currently treating with medication.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Electroencephalogram, Gait disturbance, Menorrhagia
Clinical narrative: Severe vertigo (flipping, spinning sensations - inability to walk unassisted. Onset 11/5/13 at 10 PM, continued, with varying degrees through mid-December 2013. Visual problems - reduced field of vision, double/triple vision, blurriness, movement of words on paper onset 11/5/13. Continued through January 2014. Heavy menstrual bleeding/extended periods from November 21 through January 12 bled (heavy and red) for 31 out of 50 days. Lower back pain - onset November 30, 2013, subsided by mid to late December, but still occasionally bothers. Difficulty walking/Irregular gait - onset November 5, 2013, subsided by mid-December. Fainting/Syncope - onset January 6, daily occurrences - often 2-3 times a day - through mid-March. Still has fainting episodes but frequency is reduced with medication. Tremors - uncontrolled tremors in arms and legs. Started after fainting during first week in January; by mid-January the tremors were present throughout the day, not just after fainting.  Tremors continued until early February. Possible Autoimmune Disorder - Antiphospholipid syndrome. Orthostatic Intolerance - ongoing, currently treating with medication.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Nuclear magnetic resonance imaging brain, Ophthalmological examination, Orthostatic intolerance, Syncope, Tremor
Clinical narrative: Severe vertigo (flipping, spinning sensations - inability to walk unassisted. Onset 11/5/13 at 10 PM, continued, with varying degrees through mid-December 2013. Visual problems - reduced field of vision, double/triple vision, blurriness, movement of words on paper onset 11/5/13. Continued through January 2014. Heavy menstrual bleeding/extended periods from November 21 through January 12 bled (heavy and red) for 31 out of 50 days. Lower back pain - onset November 30, 2013, subsided by mid to late December, but still occasionally bothers. Difficulty walking/Irregular gait - onset November 5, 2013, subsided by mid-December. Fainting/Syncope - onset January 6, daily occurrences - often 2-3 times a day - through mid-March. Still has fainting episodes but frequency is reduced with medication. Tremors - uncontrolled tremors in arms and legs. Started after fainting during first week in January; by mid-January the tremors were present throughout the day, not just after fainting.  Tremors continued until early February. Possible Autoimmune Disorder - Antiphospholipid syndrome. Orthostatic Intolerance - ongoing, currently treating with medication.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Vertigo, Vision blurred, Visual field defect, Visual impairment
Clinical narrative: Severe vertigo (flipping, spinning sensations - inability to walk unassisted. Onset 11/5/13 at 10 PM, continued, with varying degrees through mid-December 2013. Visual problems - reduced field of vision, double/triple vision, blurriness, movement of words on paper onset 11/5/13. Continued through January 2014. Heavy menstrual bleeding/extended periods from November 21 through January 12 bled (heavy and red) for 31 out of 50 days. Lower back pain - onset November 30, 2013, subsided by mid to late December, but still occasionally bothers. Difficulty walking/Irregular gait - onset November 5, 2013, subsided by mid-December. Fainting/Syncope - onset January 6, daily occurrences - often 2-3 times a day - through mid-March. Still has fainting episodes but frequency is reduced with medication. Tremors - uncontrolled tremors in arms and legs. Started after fainting during first week in January; by mid-January the tremors were present throughout the day, not just after fainting.  Tremors continued until early February. Possible Autoimmune Disorder - Antiphospholipid syndrome. Orthostatic Intolerance - ongoing, currently treating with medication.
Age: 73.0
Sex: M
Vaccine: HEPAB
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient called to report she has had left arm pain since she had vaccine administered.  She states she doesn't recall if the pain started on the first dose or the second dose of Twinrix given 2/19/14 and 3/18/14.  She describes the pain as aching at the site of her left deltoid and she has a sharp pain with movement she describes with external rotation of her shoulder.  She denies any other injuries.  She states it feels like a pulled muscle.  Patient is to start ibuprofen 400 mg TID with food and ice 2-3 times daily for 15-20 minutes.  She will also begin range of motion exercises.  She is to follow-up with her primary care provider if her symptoms do not improve.  I let her know I will complete a VAERS (Vaccine adverse event reporting system) notice for her and that someone may call her for follow-up.  She voiced understanding.
Age: 7.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Dizziness postural, Nausea
Clinical narrative: Following vaccines patient felt dizzy and nauseous after standing. Had patient lay down on exam table. BP laying 118/70, BP sitting 112/69, and BP standing 120/85. Patient stated he felt better and could walk. Walked patient to car and informed him to go to ER if worsens.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Back pain, Diarrhoea, Headache, Nausea, Neck pain
Clinical narrative: Neck and back pain, headache, nausea and diarrhea.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Client received Zoster vaccination by subcutaneous route to back of left arm at 11:00 am on 04/09/2014.  Morning of 04/10/14 at 9:00 AM client noticed itching and redness to the site.  By morning of 04/11/14 client noticed increased itching from upper arm to elbow, increased redness around injection site, and a lump at the injection site. Left arm painful with ambulation. Observation by this RN: Lump at injection site measures 35 x 35 mm, warm to touch.  Redness extended beyond size of lump by approximately another 35 mm. Client denies symtemic symptoms of fever or illness. Counseled on signs of increased infection, comfort measures, and encouraged her to consult with her provider about reaction, which she did.  Her provider obtained blood test for signs of infection.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Client received Zoster vaccination by subcutaneous route to back of left arm at 11:00 am on 04/09/2014.  Morning of 04/10/14 at 9:00 AM client noticed itching and redness to the site.  By morning of 04/11/14 client noticed increased itching from upper arm to elbow, increased redness around injection site, and a lump at the injection site. Left arm painful with ambulation. Observation by this RN: Lump at injection site measures 35 x 35 mm, warm to touch.  Redness extended beyond size of lump by approximately another 35 mm. Client denies symtemic symptoms of fever or illness. Counseled on signs of increased infection, comfort measures, and encouraged her to consult with her provider about reaction, which she did.  Her provider obtained blood test for signs of infection.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain upper, Culture stool, Haematochezia, Stool analysis
Clinical narrative: Bloody stools.  Patient went to ER.  Was having horrible stomach pain.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Aspartate aminotransferase increased, Blood test abnormal, Burning sensation, Colonoscopy abnormal
Clinical narrative: Severe abdominal pains after booster #3 with swelling and tightness of the arm. Booster #4 left the vaccination site inflammed for several weeks and caused stiffness in the arm. Booster #5 caused immediate burning and swelling. Booster #5 caused me to enter shock which may have been due to an allergic reaction to the shot, or adverse effect. Previous shots had adverse reactions, but nothing was done. After #5 the facility annotated it and provided a permanent exemption from shot series.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Crohn's disease, Hypersensitivity, Intestinal fistula, Local swelling, Musculoskeletal stiffness
Clinical narrative: Severe abdominal pains after booster #3 with swelling and tightness of the arm. Booster #4 left the vaccination site inflammed for several weeks and caused stiffness in the arm. Booster #5 caused immediate burning and swelling. Booster #5 caused me to enter shock which may have been due to an allergic reaction to the shot, or adverse effect. Previous shots had adverse reactions, but nothing was done. After #5 the facility annotated it and provided a permanent exemption from shot series.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Shock, Skin tightness, Swelling, Vaccination complication, Vaccination site inflammation
Clinical narrative: Severe abdominal pains after booster #3 with swelling and tightness of the arm. Booster #4 left the vaccination site inflammed for several weeks and caused stiffness in the arm. Booster #5 caused immediate burning and swelling. Booster #5 caused me to enter shock which may have been due to an allergic reaction to the shot, or adverse effect. Previous shots had adverse reactions, but nothing was done. After #5 the facility annotated it and provided a permanent exemption from shot series.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC, VARCEL
Symptoms: Incorrect dose administered, Wrong drug administered
Clinical narrative: Vaccines ordered MMR, Varicella, Prevnar and Hib. Vaccines administered MMRV, Varicella, ActHiB, Prevnar. Notified Dr. and parent was notified. No treatment initiated.
Age: 45.0
Sex: F
Vaccine: MMR, SMALL
Symptoms: Mass, Pain, Rash pruritic
Clinical narrative: PAINFUL LUMPS AT BASE OF HEAD AND BEHIND EARS, ITCHY RASH ON FACE.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Expired drug administered
Clinical narrative: Vaccine was expired on 02/15/2014.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Administered Tdap to left deltoid of seated client.  Client stood to leave, took a couple of steps, lost consciousness momentarily and fell to the floor striking head.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Administered TDAP to left deltoid of seated client. Client stood to leave, took a couple of steps, lost consciousness momentarily and fell to the floor striking head.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: A circular red spot occurred the second day the size of a quarter.  By the next day it had doubled in size.  Then it continued down the arm.  By 4/3/2014 it had diminished to a faint outline.  There was itching through all of this.
Age: 5.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Cellulitis, Cough, Ear pain, Injected limb mobility decreased, Injection site erythema
Clinical narrative: He developed mild cold symptoms the next day, no fevers, but coughing/congested.  Yesterday developed fever.  Left arm hurt so bad he could barely move it last night. Tylenol helping. Redness of arm just started yesterday evening--first began as a tiny little red bump, possibly at the site of his vaccine, then this morning it turned into a tiny little scab.  Mom drove 10 minutes to get here, and then she noticed upon arrival that his arm.  10 min later came here and his left arm was swollen and red.  Also, his left ear hurts since this morning. Other muscles sore yesterday too. Diagnosed as cellulitis.
Age: 5.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site pain, Injection site scab, Injection site swelling, Myalgia, Nasopharyngitis
Clinical narrative: He developed mild cold symptoms the next day, no fevers, but coughing/congested.  Yesterday developed fever.  Left arm hurt so bad he could barely move it last night. Tylenol helping. Redness of arm just started yesterday evening--first began as a tiny little red bump, possibly at the site of his vaccine, then this morning it turned into a tiny little scab.  Mom drove 10 minutes to get here, and then she noticed upon arrival that his arm.  10 min later came here and his left arm was swollen and red.  Also, his left ear hurts since this morning. Other muscles sore yesterday too. Diagnosed as cellulitis.
Age: 5.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: He developed mild cold symptoms the next day, no fevers, but coughing/congested.  Yesterday developed fever.  Left arm hurt so bad he could barely move it last night. Tylenol helping. Redness of arm just started yesterday evening--first began as a tiny little red bump, possibly at the site of his vaccine, then this morning it turned into a tiny little scab.  Mom drove 10 minutes to get here, and then she noticed upon arrival that his arm.  10 min later came here and his left arm was swollen and red.  Also, his left ear hurts since this morning. Other muscles sore yesterday too. Diagnosed as cellulitis.
Age: 5.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Cellulitis
Clinical narrative: He developed mild cold symptoms the next day, no fevers, but coughing/congested.  Yesterday developed fever.  Left arm hurt so bad he could barely move it last night. Tylenol helping. Redness of arm just started yesterday evening--first began as a tiny little red bump, possibly at the site of his vaccine, then this morning it turned into a tiny little scab.  Mom drove 10 minutes to get here, and then she noticed upon arrival that his arm.  10 min later came here and his left arm was swollen and red.  Also, his left ear hurts since this morning. Other muscles sore yesterday too. Diagnosed as cellulitis.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Erythema, Local swelling
Clinical narrative: Mop states that child received varicella vaccine on the 24th of march 2014, and at first it was ok, but yesterday the spot started to look like it was swelling, and turned red. Child does not appear to be bothered, by the spot, and does not poke at it or scratch at it.  No fevers. Brother with cellulitis of his arm after this vaccination requiring recent hospitalization for IV antibiotics
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Bump and redness.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fatigue, Feeling abnormal, Pain, Pain in extremity, Pyrexia
Clinical narrative: Was very tired after shots, took Tylenol at 1:00 PM with c/o sore arms. Went to bed at 7PM woke up at 10:00 felt hot to touch, did not take temperature, c/o feeling generally bad. The next morning (Fri.) felt generally bad, had fever of 100.4 at 9:15. Refused Tylenol. Just hurt all over, stayed in bed Friday and Saturday with fever and over all achy.  Sunday felt better, able to get up and go to front room, but did not feel  100%.  By Monday no fever, aches were gone, felt back to normal.