chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patinet received improperly stored pedvax; no adverse event; This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-JUN-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S023646; expiry date: 31-MAR-2022) via unspecified route for prophylaxis (product storage error). The vaccine was stored above the temperature of 47°F/9°C 9.15C for 15 minutes. The vaccine had a previous temperature excursion of above 47°F/9°C 8.62C for 11 minutes. The call was because of a digital data logger. No additional adverse effect reported. The outcome of the events was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash, Rash papular
Clinical narrative: allergic reaction; rash that looks like small bumps from my side around to the middle of my front trunk; This case was reported by a other health professional via interactive digital media and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced allergic reaction and raised rash. On an unknown date, the outcome of the allergic reaction and raised rash were unknown.   It was unknown if the reporter considered the allergic reaction and raised rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had an allergic reaction. The patient had a rash that looks like small bumps going from my side around to the middle of my front trunk.  The reporter asked what could did to help get over this.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in the arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix approximately 2 months ago and had pain in the arm he received his vaccine.  The reporter stated that pain just started (the day of reporting). The reporter did not consent to follow up. No additional details were at the time of reporting. The reporter might call back.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Rash pustular, Rash vesicular
Clinical narrative: chickenpox-like rash; rash is pustular and vesicular.; red and itchy along a nerve; itchy along a nerve / comes and goes in waves and in patches; It comes and goes in waves and in patches; "welt" on his right ankle/fingers; This case was reported by a pharmacist via call center representative and described the occurrence of varicella-like rash in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cyst removal (cyst had been presented for years) and bug bite. Previously administered products included Shingrix (received 1st dose on an unknown date).   On 27th May 2020, the patient received the 2nd dose of Shingrix. On 8th June 2020, 12 days after receiving Shingrix, the patient experienced varicella-like rash, vesiculopustular rash, red rash, itchy rash, patchy rash and welts. On an unknown date, the outcome of the varicella-like rash, vesiculopustular rash, red rash, itchy rash, patchy rash and welts were unknown.   It was unknown if the reporter considered the varicella-like rash, vesiculopustular rash, red rash, itchy rash, patchy rash and welts to be related to Shingrix.  Additional details were reported as follows: After receiving Shingrix, the patient developed a chicken pox type rash that was pustular and vesicular in nature, but was not painful.  The rash was red and itchy along a nerve. It came and went in waves and in patches. The patient had bug bites from doing yard work but started to notice that the areas started to appear on his trunk along the areas where shingles usually occurred. The patient also had areas on both legs and arms that seemed to be appeared in waves and go away.  At the time of reporting, the patient had what appeared to be a welt on his right ankle and on his middle and index fingers. The reporter was consented to follow up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: chickenpox-like rash; rash is pustular and vesicular.; red and itchy along a nerve; itchy along a nerve / comes and goes in waves and in patches; It comes and goes in waves and in patches; "welt" on his right ankle/fingers; This case was reported by a pharmacist via call center representative and described the occurrence of varicella-like rash in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cyst removal (cyst had been presented for years) and bug bite. Previously administered products included Shingrix (received 1st dose on an unknown date).   On 27th May 2020, the patient received the 2nd dose of Shingrix. On 8th June 2020, 12 days after receiving Shingrix, the patient experienced varicella-like rash, vesiculopustular rash, red rash, itchy rash, patchy rash and welts. On an unknown date, the outcome of the varicella-like rash, vesiculopustular rash, red rash, itchy rash, patchy rash and welts were unknown.   It was unknown if the reporter considered the varicella-like rash, vesiculopustular rash, red rash, itchy rash, patchy rash and welts to be related to Shingrix.  Additional details were reported as follows: After receiving Shingrix, the patient developed a chicken pox type rash that was pustular and vesicular in nature, but was not painful.  The rash was red and itchy along a nerve. It came and went in waves and in patches. The patient had bug bites from doing yard work but started to notice that the areas started to appear on his trunk along the areas where shingles usually occurred. The patient also had areas on both legs and arms that seemed to be appeared in waves and go away.  At the time of reporting, the patient had what appeared to be a welt on his right ankle and on his middle and index fingers. The reporter was consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness of injection site; Raised at the injection site; hot to the touch sensation; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number G72Z4, expiry date 13th March 2022) for prophylaxis.   On 16th June 2020, the patient received Shingrix. On 18th June 2020, 2 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The batch number was updated as G7274 to G72Z4, as per sales data sheet. The suspect vaccine lot number provided by the reporter did not pull up in database. The patient received the Shingrix and experienced an injection site reaction that included redness, hot to the touch sensation, and a raised injection site. The injection site reaction was 2 inches in diameter, with no associated drainage or change in sensation. The reporter consented to follow up. The reporter provided limited information at time of call.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Hallucination, auditory, Hallucination, visual, Injection site pain, Insomnia
Clinical narrative: Was hallucinating.  Seeing and hearing things without a fever. Was up most of the night.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Body temperature increased, Decreased appetite, Discomfort, Hallucination, visual, Injection site movement impairment
Clinical narrative: Was hallucinating.  Seeing and hearing things without a fever. Was up most of the night.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site pain, Insomnia
Clinical narrative: Was hallucinating.  Seeing and hearing things without a fever. Was up most of the night.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Vasovagal syncope
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Pain
Clinical narrative: Pain in left.  Headaches. Loss of appetite.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation, Product preparation issue
Clinical narrative: Pharmacy believes that Shingrix was reconstituted, patient was given the vaccine and upon peeling the label off to document the vaccine on the patient consent form noticed that the white tablet of powder was still in the vial. Patient was notified that she only received diluent and was re-vaccinated.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Blood culture negative, Chest X-ray normal, Computerised tomogram normal, Electroencephalogram normal, Full blood count normal
Clinical narrative: Wednesday morning 6/10/2020 had well visit and 1 year vaccines Wednesday night at 7pm had increased fussiness, vomited, pale, and "lethargic," started to seize, upper body mostly. Called 911 and taken to hospital Temp in ER 101,  Went home that same night, seized again around midnight, went back to ER, still had a fever, therefore admitted wed through friday, fevers continued to go up and down during admission COVID negative, CT, chest xray, CBC, blood culture, urine, BMP, & EEG normal Fever free since hospital visit and without any additional symptoms.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Irritability, Lethargy, Metabolic function test normal, Pallor, Pyrexia
Clinical narrative: Wednesday morning 6/10/2020 had well visit and 1 year vaccines Wednesday night at 7pm had increased fussiness, vomited, pale, and "lethargic," started to seize, upper body mostly. Called 911 and taken to hospital Temp in ER 101,  Went home that same night, seized again around midnight, went back to ER, still had a fever, therefore admitted wed through friday, fevers continued to go up and down during admission COVID negative, CT, chest xray, CBC, blood culture, urine, BMP, & EEG normal Fever free since hospital visit and without any additional symptoms.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: SARS-CoV-2 test negative, Seizure, Urine analysis normal, Vomiting
Clinical narrative: Wednesday morning 6/10/2020 had well visit and 1 year vaccines Wednesday night at 7pm had increased fussiness, vomited, pale, and "lethargic," started to seize, upper body mostly. Called 911 and taken to hospital Temp in ER 101,  Went home that same night, seized again around midnight, went back to ER, still had a fever, therefore admitted wed through friday, fevers continued to go up and down during admission COVID negative, CT, chest xray, CBC, blood culture, urine, BMP, & EEG normal Fever free since hospital visit and without any additional symptoms.
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: administered a dose of improperly stored; No adverse symptoms were reported.; This spontaneous report was received from a nurse practitioner and refers to a 2-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-JUN-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # reported as S007072 and expiration date was reported as 24-JAN-2022 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. Lot number S007072 is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 47 degrees Fahrenheit for 10 minutes. Data logger was involved. There were no previous excursions reported. Action taken with the suspect vaccine and the outcome of the event was not reported.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: lhe patient was administered a dose of improperly stored; No adverse symptoms were reported; This spontaneous report was received from a nurse and refers to an 18-year-old patient of an unknown gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided. The report refers to one patient and one combination product.  On 04-JUN-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number: R025726, expiration date: 26-MAY-2021 for prophylaxis (exact dose and route of administration was not provided).  The vaccine experienced temperature excursion above 47 degrees Fahrenheit (47.1 degrees Fahrenheit) for 10 minutes. Previous temperature excursion was not detected. The digital data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional adverse event; a 19-year-old patient was inadvertently administered a pediatric dose of VAQTA; This spontaneous report as received from a nurse and refers to a 19-year-old patient of unknown gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 18-JUN-2020, the patient was inadvertently administered a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (route of administration was not reported), lot # T001419 and expiration date 06-JAN-2021, for prophylaxis (incorrect dose administered). No additional adverse event reported.
Age: 44.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event; patient received the first dose of GARDASIL 9 on 12/6/2019, and the second dose of GARDASIL 9 on 6/18/2020; 44-year-old patient received the first dose of GARDASIL 9; This spontaneous report as received from a pharmacist refers to a 44-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 06-DEC-2019, the patient was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 18-JUN-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1602284, expiration date 26-SEP-2021 (dose and route of administration were not reported) for prophylaxis. There was no adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse effects; an administered dose of VARlVAX underwent a temperature excursion prior to being administered to 1 patient on 06/16/2020; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information regarding patient's medical history, concomitant medications and concurrent conditions was provided.     On 16-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S024362, expiration date 06-AUG-2021 2019 (route of administration, dose and frequency were not reported) for prophylaxis. Digital Data logger was involved. The vaccine was stored at the temperature that was reported as from 10.8 degrees of F for 2 hours. There was no previous temperature excursion reported.  No known adverse effects reported.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles rash / Shingles outbreak; rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included autism.   On 11th February 2020, the patient received the 1st dose of Shingrix. On 9th June 2020, 119 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix  About a week ago from the date of reporting, the patient developed shingles rash. The patient had been treated for shingles outbreak for the last week. Treatment was unspecified. While the rash was active, the patient received the 2nd dose of Shingrix on 16th June 2020 (batch number 4ME42 expiry date 14th November 2021). No further symptoms were reported.  The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hyperaesthesia, Sensory disturbance
Clinical narrative: Feeling tired; Strange feeling in right arm; strange feeling in his right arm that is sensitive to touch; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020, the patient received Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced tiredness, abnormal sensation of limbs and touch sensitivity increased. On an unknown date, the outcome of the tiredness, abnormal sensation of limbs and touch sensitivity increased were unknown.   It was unknown if the reporter considered the tiredness, abnormal sensation of limbs and touch sensitivity increased to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. After receiving the 1st dose of Shingrix, the patient experienced feeling more tired. Last month, he experienced a strange feeling in the patient's right arm that was sensitive to touch. The patient reported no outward signs of irritation. The reporter did not consent to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Hypersensitivity, Urticaria
Clinical narrative: Difficulty breathing; Hives; This is a spontaneous case initially received from other health professional via Agency (reference number: SEQW20-00497) on 22-Jun-2020, concerning a female patient of unknown age.   The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [influenza virus vaccine polyvalent; dose, route of administration, anatomical location, batch number and expiry date: not reported] for influenza prophylaxis.    On the same date, after flu vaccine injection, the patient experienced hives and difficulty breathing.   It was reported that patient's physician felt the reaction was related to the preservative in the vaccine.   The outcome of the events hives and difficulty breathing was not reported.   The events of hives and difficulty breathing were assessed as serious due to the criterion of medical significance, per company.     The patient's physician considered the events as related to INN Flu Vaccine Seasonal.  Company comment: A female patient developed dyspnoea and urticaria on the same day after vaccination with the suspect product INN Flu Vaccine Seasonal for prophylaxis. Chronology seems suggestive. The patient's medical history and concomitant medications were not reported. In the source it was not specified wether allergic reraction occurred however, reported events and temporality suggest towards allergic reaction. With information presented, causality is assessed as possibly related for both events.; Sender's Comments: A female patient developed dyspnoea and urticaria on the same day after vaccination with the suspect product INN Flu Vaccine Seasonal for prophylaxis. Chronology seems suggestive. The patient's medical history and concomitant medications were not reported. In the source it was not specified wether allergic reraction occurred however, reported events and temporality suggest towards allergic reaction. With information presented, causality is assessed as possibly related for both events.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Intensive care, Muscular weakness, Plasmapheresis
Clinical narrative: Vaccine given 6/2/2020. Guillain-Barre Syndrome diagnosed on 6/19/2020 Admitted to ICU, intubated and started on plasma exchange therapy. Planned to stay inpatient ongoing at least thru next week
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient should have received Tdap and instead received DTaP . There was no adverse outcome.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site is red, raised, warm, itchy. Area is size of quarter to half dollar.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Sore left arm at injection site shortly after shot administered.  Mild chills approximately 14 hours after injection, followed by initiation of a mild fever (~99-100 deg F) approximately 16 hours after injection.  Fever appeared to last approximately 10 hours.  Body temperature is currently back to normal with no chills or  other adverse side effects (aside from continued left arm soreness, some muscle ache, fatigue).
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Fatigue, Insomnia, Pruritus, Rash
Clinical narrative: Fatique, Burning rash on my left arm from the top of my shoulder down to the elbow, Saturday the 19th a full rash from my right arm all the way down to my fingers. Burning and extreme itching, symptoms have continued through yet another day, today is Wednesday the 24th of June 2020.  Some of the rash has turned to small blisters, the rash today looks like hives.  It is much more aggressive at night making it difficult to sleep. The itch is something i have never experienced.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Rash vesicular, Urticaria
Clinical narrative: Fatique, Burning rash on my left arm from the top of my shoulder down to the elbow, Saturday the 19th a full rash from my right arm all the way down to my fingers. Burning and extreme itching, symptoms have continued through yet another day, today is Wednesday the 24th of June 2020.  Some of the rash has turned to small blisters, the rash today looks like hives.  It is much more aggressive at night making it difficult to sleep. The itch is something i have never experienced.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Asthma, Bronchial hyperreactivity, Condition aggravated, Dyspnoea
Clinical narrative: Parent called after leaving the office stating the patient started throwing up in the car. Mom states the patient was fine while leaving the office, not upset or crying. Mom denied other symptoms.  Mom states the patient has no history of adverse reactions after receiving vaccines in the past and only known allergy is peanut. Informed mom that nurse would call back with further instruction after consulting with provider. Nurse called mom back and mom stated she was at the ED with patient because after hanging up the patient started having difficulty breathing. Patient received Epi, Albuterol, and prednisolone. Patient diagnosed with reactive airway disease without complication, unspecified asthma severity, and anaphylaxis
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: Parent called after leaving the office stating the patient started throwing up in the car. Mom states the patient was fine while leaving the office, not upset or crying. Mom denied other symptoms.  Mom states the patient has no history of adverse reactions after receiving vaccines in the past and only known allergy is peanut. Informed mom that nurse would call back with further instruction after consulting with provider. Nurse called mom back and mom stated she was at the ED with patient because after hanging up the patient started having difficulty breathing. Patient received Epi, Albuterol, and prednisolone. Patient diagnosed with reactive airway disease without complication, unspecified asthma severity, and anaphylaxis
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral, Throat tightness
Clinical narrative: Pt called back to say she experienced tingling in the back of her tongue and tightness in her throat about 45 minutes after vaccination.  She took 25mg of Benadryl and said she felt it was better.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever to 101.7 and full body rash
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Hyperhidrosis, Nausea, Photophobia, Pyrexia
Clinical narrative: Nausea, headache, photophobia, subjective fever, sweats
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Patient reported a fever of 103 F, and she also reported a welt the size of 8 inches round.  She was advised to take tylenol or ibuprofen for the fever, to ice the arm, and to take some benadryl.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Pyrexia
Clinical narrative: SEVERAL HOURS AFTER VACCINE PATIENT DEVELOPED A 102 FEVER. SOON AFTER SHE HAD A HEADACHE AND UPSET STOMACH. SYMPTOMS HAD NOT RESOLVED AS OF 6/23/20. PHARMACIST CALLED PATIENT ON 6/24/20 TO CHECK IN AND HAS NOT HEARD BACK.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Heart rate increased, Lethargy, Supraventricular tachycardia, Vomiting
Clinical narrative: 72 hours after these vaccines, my son became very lethargic, starting vomiting & had a heart rate of 300
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was supposed to receive Pneumovax but she received Prevnar by accident. She had already received Prevnar last year and she was due for Pneumovax. She doesn't really report any side effects.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient received vaccine 5/28/20 she called  late evening saying that her arm was hot, swollen and painful. She also had difficulty lifting her arm.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: soreness in her left arm.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea that lasted for one month after getting vaccinations.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Induration, Injection site erythema, Injection site induration, Injection site reaction, Pyrexia
Clinical narrative: Low grade fever day after immunizations with a 5 cm  area of redness, without enduration or heat. On lower right leg and left wrist  1 cm papular rash with endurated center that is yellow.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Rash papular
Clinical narrative: Low grade fever day after immunizations with a 5 cm  area of redness, without enduration or heat. On lower right leg and left wrist  1 cm papular rash with endurated center that is yellow.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Weight bearing difficulty
Clinical narrative: Patient had a large red knot on the injection site, complained had trouble putting weight on that side especially sitting or lying down for the next couple  days following the administration of the vaccine.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site macule, Injection site pain
Clinical narrative: From 12/4 visit:  HPI: Pt received immunizations on Monday. Yesterday they started to have redness and swelling at injections sites on both legs.  Pt has a lot of pain in both legs and is limping. Legs are itching and keeping pt awake during the night. Exam: anterior thighe on teh Rt with idnuration of 4cm and erythema extends to 10cm , on the Lt induration about 5cm however on the medial side there are lenear collection of vesicles, clear in a ring ~5.5 cm..the erythema extends to 12 cm diameter..slightly tender..  From 12/6 f/u visit: HPI: Received Pentacel and Prevnar #4 12/2 4 days ago Pentacel on left and Prevnar on right  very large area of erythema, warmth, induration, and blisters with left worse than right   seen 2 days ago and instructed to give Zyrtec fever 100.2 starting 2 days ago   didn't sleep well last 2 nights otherwise wnl appetite and activity, gait was affected, better today   parents concerned about allergy and future ramifications Exam:left anterior lateral thigh with 12 cm x 10 cm pen outline with mostly resolving pink macular and 1 cm area of induration at visible puncture site lateral thigh, right anterior thigh with 10.5 cm x 7 cm pen outline also with resolving macular pink within it and similar 1 cm area of induration, no warmth, no edema, and NT either thigh, flattened semi circle of vesicles on left anterior thigh, nl gait
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site pruritus, Injection site swelling, Injection site vesicles, Injection site warmth, Insomnia
Clinical narrative: From 12/4 visit:  HPI: Pt received immunizations on Monday. Yesterday they started to have redness and swelling at injections sites on both legs.  Pt has a lot of pain in both legs and is limping. Legs are itching and keeping pt awake during the night. Exam: anterior thighe on teh Rt with idnuration of 4cm and erythema extends to 10cm , on the Lt induration about 5cm however on the medial side there are lenear collection of vesicles, clear in a ring ~5.5 cm..the erythema extends to 12 cm diameter..slightly tender..  From 12/6 f/u visit: HPI: Received Pentacel and Prevnar #4 12/2 4 days ago Pentacel on left and Prevnar on right  very large area of erythema, warmth, induration, and blisters with left worse than right   seen 2 days ago and instructed to give Zyrtec fever 100.2 starting 2 days ago   didn't sleep well last 2 nights otherwise wnl appetite and activity, gait was affected, better today   parents concerned about allergy and future ramifications Exam:left anterior lateral thigh with 12 cm x 10 cm pen outline with mostly resolving pink macular and 1 cm area of induration at visible puncture site lateral thigh, right anterior thigh with 10.5 cm x 7 cm pen outline also with resolving macular pink within it and similar 1 cm area of induration, no warmth, no edema, and NT either thigh, flattened semi circle of vesicles on left anterior thigh, nl gait
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia
Clinical narrative: From 12/4 visit:  HPI: Pt received immunizations on Monday. Yesterday they started to have redness and swelling at injections sites on both legs.  Pt has a lot of pain in both legs and is limping. Legs are itching and keeping pt awake during the night. Exam: anterior thighe on teh Rt with idnuration of 4cm and erythema extends to 10cm , on the Lt induration about 5cm however on the medial side there are lenear collection of vesicles, clear in a ring ~5.5 cm..the erythema extends to 12 cm diameter..slightly tender..  From 12/6 f/u visit: HPI: Received Pentacel and Prevnar #4 12/2 4 days ago Pentacel on left and Prevnar on right  very large area of erythema, warmth, induration, and blisters with left worse than right   seen 2 days ago and instructed to give Zyrtec fever 100.2 starting 2 days ago   didn't sleep well last 2 nights otherwise wnl appetite and activity, gait was affected, better today   parents concerned about allergy and future ramifications Exam:left anterior lateral thigh with 12 cm x 10 cm pen outline with mostly resolving pink macular and 1 cm area of induration at visible puncture site lateral thigh, right anterior thigh with 10.5 cm x 7 cm pen outline also with resolving macular pink within it and similar 1 cm area of induration, no warmth, no edema, and NT either thigh, flattened semi circle of vesicles on left anterior thigh, nl gait
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Decreased appetite, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms. Fatigue. Myalgia anorexia. Abdominal ache
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain
Clinical narrative: Patient reports experiencing some soreness with moderate pain, headache, muscle pain, and overall tiredness. Patient was recommended to start taking Tylenol to help with symptoms.
Age: 56.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Body temperature increased, Erythema, Fatigue, Headache, Injection site warmth
Clinical narrative: headache, temp 99.8, fatigue, muscle aches, redness, pain, heat at injection site, restlessness, 8 small red, itchy bumps on upper thighs. Still have symptoms 72 hours later. Took ibuprofen 400mg every 6 hours.
Age: 56.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Myalgia, Pain, Rash, Rash erythematous, Rash pruritic
Clinical narrative: headache, temp 99.8, fatigue, muscle aches, redness, pain, heat at injection site, restlessness, 8 small red, itchy bumps on upper thighs. Still have symptoms 72 hours later. Took ibuprofen 400mg every 6 hours.
Age: 56.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Restlessness
Clinical narrative: headache, temp 99.8, fatigue, muscle aches, redness, pain, heat at injection site, restlessness, 8 small red, itchy bumps on upper thighs. Still have symptoms 72 hours later. Took ibuprofen 400mg every 6 hours.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Left arm pain and swelling
Age: 1.92
Sex: M
Vaccine: FLUA3
Symptoms: Ear pain, Extra dose administered
Clinical narrative: he was pulling at his left ear, ear ache  he received flu6mo> according to his record im not sure if i marked the right one above.   Also i was told to report this... I have a question I was hoping you could help me with.  Ok in  2014 my son got 3 flu vaccines. not his first round of flu shots. First flu vaccine was 10-31-12 it was fluzone 6mo> . Why would he get 3in 1 year, that?s too many.  He got ... *Flu 6mo> on 1-29-2014 *Fluarix quad on 9-17-2014 *Flu-mist 10-31-2014   ??? I would really appreciate your help in figuring out why.  Thanks  I will make 2 other VAERS reports for those other two flu shots in 2014 and adverse events that followed.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza, Myalgia
Clinical narrative: Chills, severe muscle aches.  Feels like I have the flu coming on
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropathy, Fatigue
Clinical narrative: Patient started feeling fatigue and joint two days post vaccination that has persisted until present time of reporting
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Extra dose administered, Upper respiratory tract congestion, Viral rhinitis
Clinical narrative: event was on 11/4/14 he was at the dr for a 2 yr 9 mo check up whereI told the dr he had upper airway congestion. Dr dx as viral rhinitis.  ?- I made another VAERS report from vaccine date 1/29/14 and event date 2-21-14 here is another tie in with  it. He was over vaccinated wasnt he?   I have a question I was hoping you could help me with.  Ok in  2014 my son got 3 flu vaccines. not his first round of flu shots. First flu vaccine was 10-31-12 it was fluzone 6mo> . Why would he get 3in 1 year, that?s too many.  He got ... *Flu 6mo> on 1-29-2014 *Fluarix quad on 9-17-2014 *Flu-mist 10-31-2014   ??? I would really appreciate your help in figuring out why.  Thanks
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Pt had a rash all over left side of body. She also had bumps and they were itchy.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Bronchitis, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: on 10-14-15 he was given flu la1v4 nasal noy sure if i marked it right above.  On 12/21/2015 he went to the dr he had been sick for a week or so fever, 3 weeks before sore throat possibly strep . The dr dx with bronchitis.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Bronchitis, Cough, Pyrexia
Clinical narrative: not sure if i marked the right vaccine above ..on 11/14/2016 he had flu 11v4 MDV.  Event was on 12/22/16 he went to the dr for a cough and fever that had been going on for about 1-2 weeks, dr dx him with bronchitis.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin, Rash
Clinical narrative: Developed a rash on right side of torso and back near my waist.  Skin very sensitive to touch.   Under right arm pit and forearm also sensitive to touch but no rash at this point.
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Gastritis, Otitis media, Pharyngitis, Pyrexia, Vomiting projectile
Clinical narrative: I do not know if i put the right vaccine above ...on 10/31/2012 he had the fluzone 6mo>.   Event he actually had two appts following this vaccine. first- 12/6/12 I took him to quick care,  he was projectile vomiting they dx him as gastritis. second took him to emergency room, he had a fever of 106, they dx as pharyngitis and otitis media.
Age: 42.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Antibody test, CSF cell count, CSF glucose, Differential white blood cell count, Full blood count
Clinical narrative: Paresthesias, Guilliam-Barre type syndrome
Age: 42.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Gram stain, Guillain-Barre syndrome, Lumbar puncture, Metabolic function test, Paraesthesia
Clinical narrative: Paresthesias, Guilliam-Barre type syndrome
Age: 42.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Polymerase chain reaction, SARS-CoV-2 test, West Nile virus test
Clinical narrative: Paresthesias, Guilliam-Barre type syndrome
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Otitis media, Pyrexia
Clinical narrative: I am not sure if I marked the right vaccines but on 8-16-12 he had PENTA (DTP AND PV on his shot record),  HIB, HEP B, PCV  Event on 9-16-2012 he had a fever of 102.8 I took him to the ER the night before but they made us sit forever like 4 hours bc of other emergencies so we decided to go to quickcare the next day They dx him with otitis media.
Sex: M
Vaccine: HEP
Symptoms: Upper respiratory tract infection
Clinical narrative: Im not sure what hep b was given, if i marked the correct one.   Event- 3-8-12 took him to his dr he was dx with URI.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Bronchial hyperreactivity, Irritability, Pyrexia
Clinical narrative: I do not know if i put the vaccines down right he had them done with the health dept they wouod know.  Event: Reactive airway disease on 5-16-13. I remember fever and stuff after vaccines, cranky etc. I never questioned vaccines before but looking back my kids were all effected after every one of them.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Rash
Clinical narrative: Rash on arm x 3 days then headache x additional 7 days
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever last night/ red, swollen at injection site mom gave Benadryl and ice pack no fever, no pain at this time-
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure increased, Contusion, Dizziness, Fall, Head injury
Clinical narrative: 1. Patient calm at time of vaccine administration (patient was sitting on exam table) 2. About 5 seconds after administration patient fell backward, hit head on sheet rock wall. Patient lay flat on exam table, hitting her head on side wall adjacent to the exam table 3 Doctor examined patient with a minute: patient's feet were elevated: Blood pressure elevated, patient expressed dizziness, blackout, sore throat, and severe pain on arm of vaccine site blood pressure readings follow 148/88; 134/72 at 10 min intervals and 30 minutes later BP taken again 108/68 4. Head contusion, no physical abnormality of scalp 5. Patient scheduled for follow up in 2 days 6. Mother instructed to take patient to ER if worsen 7. Patient left office accompanied by moth walking and stable
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Oropharyngeal pain, Vaccination site pain
Clinical narrative: 1. Patient calm at time of vaccine administration (patient was sitting on exam table) 2. About 5 seconds after administration patient fell backward, hit head on sheet rock wall. Patient lay flat on exam table, hitting her head on side wall adjacent to the exam table 3 Doctor examined patient with a minute: patient's feet were elevated: Blood pressure elevated, patient expressed dizziness, blackout, sore throat, and severe pain on arm of vaccine site blood pressure readings follow 148/88; 134/72 at 10 min intervals and 30 minutes later BP taken again 108/68 4. Head contusion, no physical abnormality of scalp 5. Patient scheduled for follow up in 2 days 6. Mother instructed to take patient to ER if worsen 7. Patient left office accompanied by moth walking and stable
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer and a currently 77 year old female patient regarding a case in litigation on 18-JUN-2020. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On an unspecified date in December 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) at a clinic as prophylaxis. On an unspecified date, as a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer shingles, including any and all of its sequelae; had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The patient also required and/or would require more health care and services and did incur medical, health, incidental and related expenses; and would in the future be required further medical/or hospital care, attention, and services. At the reporting time, the outcome of shingles was considered as not recovered. The reporters considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).    The reporters considered the event of shingles to be disabling.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Injection site erythema
Clinical narrative: Patient described initially having red, hard, painful and itchy sores at injection site on right arm and immediately below at midline. Pt thought it was just the adverse reactions that are listed on the VIS, but after receiving an antibiotic SMZ-TMP for a bladder infection 2 weeks later, these symptoms returned in the same area. Pt visited MD who felt patient had cellulitis and prescribed cephalexin which cleared the issue.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site urticaria, Injection site warmth, Muscular weakness
Clinical narrative: Patient described initially having red, hard, painful and itchy sores at injection site on right arm and immediately below at midline. Pt thought it was just the adverse reactions that are listed on the VIS, but after receiving an antibiotic SMZ-TMP for a bladder infection 2 weeks later, these symptoms returned in the same area. Pt visited MD who felt patient had cellulitis and prescribed cephalexin which cleared the issue.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Patient described initially having red, hard, painful and itchy sores at injection site on right arm and immediately below at midline. Pt thought it was just the adverse reactions that are listed on the VIS, but after receiving an antibiotic SMZ-TMP for a bladder infection 2 weeks later, these symptoms returned in the same area. Pt visited MD who felt patient had cellulitis and prescribed cephalexin which cleared the issue.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Cystitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient described initially having red, hard, painful and itchy sores at injection site on right arm and immediately below at midline. Pt thought it was just the adverse reactions that are listed on the VIS, but after receiving an antibiotic SMZ-TMP for a bladder infection 2 weeks later, these symptoms returned in the same area. Pt visited MD who felt patient had cellulitis and prescribed cephalexin which cleared the issue.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site ulcer
Clinical narrative: Patient described initially having red, hard, painful and itchy sores at injection site on right arm and immediately below at midline. Pt thought it was just the adverse reactions that are listed on the VIS, but after receiving an antibiotic SMZ-TMP for a bladder infection 2 weeks later, these symptoms returned in the same area. Pt visited MD who felt patient had cellulitis and prescribed cephalexin which cleared the issue.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Patient reported a rash on both legs with welts that arose the day after receiving the vaccine. She reported her symptoms to her physician and was prescribed prednisone to treat the rash.