chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a pharmacist referring to a 39 year old male patient. The patient's concurrent conditions included vitamin D deficiency, varicose vein, onychomycosis, insomnia, human immunodeficiency virus (HIV), generalized anxiety disorder, genital herpes, rhinitis allergic and shift work disorder. Concomitant medication included vilazodone hydrochloride (VIIBRYD), valacyclovir, trazodone, emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide fumarate (ODEFSEY), eszopiclone (LUNESTA), vitamin D2 and tadalafil (CIALIS). On 11-JUL-2017, the patient received a dose of PNEUMOVAX 23 , lot # N010109, expiration date 20-NOV-2018 (dose and route not reported), in the right deltoid for prophylaxis. He felt discomfort at the injection site, had a fever of 102.8 (unit not provided) and had sweats on the evening of 11-JUL-2017. Then he was relieved with a cool bath. The patient called the office on 12-JUL-2017 to report "injection-site pain and fever of 101(unit not provided)" and was given a prescription for meloxicam (MOBIC). On an unspecified date in July 2017, the patient went to the emergency room at a hospital for pain, swelling and redness at the injection site. He received intravenous fluids and was released to home on an unspecified date. After the emergency room visit, on an unspecified date in July 2017, the patient's upper deltoid had redness, swelling and was warm to touch starting from his shoulder to just above his elbow. He was prescribed warm compress. He received laboratory tests including ultrasound of the right arm, complete blood count (cbc) with differential, blood cultures and comprehensive metabolic panel. The patient started on doxycycline on 14-JUL-2017. On 15-JUL-2017, ultrasound report showed mild swelling with no discreet fluid collection. The patient was tolerating doxycycline and the swelling, tenderness and pain in his arm had improved. The patient missed three days of work. At the time of the report, the patient was recovering from all of events. The causality between the events and PNEUMOVAX 23 was not reported. This is one of several report received the same source.; Sender's Comments:  US-009507513-1707USA011016:
double respitory and heart rate.  Breathing difficulty.  bone marrow produced 24,000 extra white blood cells signifying an infection. high blood sugar levels.  Vaccine accidently overdosed 2x. 10/8/09 Hospital medical records received for 6/24/2009-7/2/2009. FINAL DX: r/o suspected sepsis; hypoglycemia; tachypnea; hyperbilirubinemia; feeding/growth & nutrition issues. Records reveal patient 38-wk preemie born via spontaneous vaginal delivery following good prenatal care.  Pregancy complicated w/H1N1 infection tx w/tamiflu 5 wks prior to delivery & asymptomatic for 1 wk prior to delivery.  Apgars 8/9 at 1/5 min.  Temp instability then increased respiratory rate from 78 to 88, glucose 92 & transferred to NICU.  Tx w/IVF & IV antibiotics x 7 days.  O2 sats 96% on RA.  Improved & d/c to home.
pt recv vax & pt exp MS;pharmacist reported 3 patients;they were assigned WAES96051400 through 96051402;No further details were provided;
TEENAGER RECIEVED MENACTRA VACCINE ON 8/8/2007. PER PARENT REPORT IN ABOUT 12 HRS SHE DEVELOPED TINGLING IN FINGERS, HEADACHE AND WEAKNESS IN EXTREMITIES. ADMITTED TO HOSPITAL FOR GUILLAIN-BARRE SYNDROME.  11/16/07 Reviewed hospital medical records which reveal paitent experienced LE paralysis & paresthesias day after vax.  Admitted 8/9-8/12/2007.  Intensivist consult done in ER & dx as probably early GBS. Paralysis resolved on admit. Tx w/IVIG but patient developed high fever & tachycardia & IVIG was d/c'd.  Then developed bradycardia which resolved by next day.  Neuro consults x 2 done & neither agreed w/GBS dx.  FINAL DX: acute paralysis of LE's, resolved; reaction to IVIG, resolved; fever, resolved; bradycardia, resolved.
Information has been received from a physician concerning a 32 year old male with a history of hypertension and no drug reactions/allergies, who in 1976 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy included hydrochlorothiazide. In 1993, the patient was vaccinated with a dose of either measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) or (measles virus vaccine live (Enders-Edmonston) (manufacturer unknown). The patient now has an equivocal measles antibody titer. No other information is available at this time. Lab diagnostics studies performed: equivocal measles antibody titer. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
9 days after vaccination, patient developed local site reaction where 2 inch wide by 6 inch long square area of erythema and induration developed.
was hurting so bad, body ache; usually doesn't sleep good, and took two more Tylenol and doze off; worst headache,head was about to burst open; temperature  normally is 97.4°f and their temperature was 100.2°F; got chills,real bad chills,but body didn't felt warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (was hurting so bad, body ache), INSOMNIA (usually doesn't sleep good, and took two more Tylenol and doze off), CHILLS (got chills,real bad chills,but body didn't felt warm), HEADACHE (worst headache,head was about to burst open) and PYREXIA (temperature  normally is 97.4°f and their temperature was 100.2°F) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007b21a and 022m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, METHIMAZOLE, SIMVASTATIN, SALBUTAMOL SULFATE (PROAIR DIGIHALER), FISH OIL (OMEGA 3 FISH OIL [FISH OIL]), DIPHENHYDRAMINE and METFORMIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (got chills,real bad chills,but body didn't felt warm). On 23-Nov-2021, the patient experienced PAIN (was hurting so bad, body ache), INSOMNIA (usually doesn't sleep good, and took two more Tylenol and doze off), HEADACHE (worst headache,head was about to burst open) and PYREXIA (temperature  normally is 97.4°f and their temperature was 100.2°F). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. On 24-Nov-2021, HEADACHE (worst headache,head was about to burst open) and PYREXIA (temperature  normally is 97.4°f and their temperature was 100.2°F) had resolved. At the time of the report, PAIN (was hurting so bad, body ache), INSOMNIA (usually doesn't sleep good, and took two more Tylenol and doze off) and CHILLS (got chills,real bad chills,but body didn't felt warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2021, Body temperature: 100.2 (High) 100.2 Degree F.
Patient was accidentally given Pfizer vaccine as a second dose when they had previously received Moderna vaccine.
After leaving clinic patient went home took a nap, upon awakening, he was unable to see out of right eye.
Vertigo started at 8pm day after vaccine and worsened. Increased restless leg,severe headache
No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to an 18-month-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 24-MAR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Flu like symptoms; Sore throat; Heart starts pounding / Heart beating; Chest hurts / Slight soreness in sternum area; Shortness of breath; Hot / Felt very very hot; Arms are shaking uncountably; Achy all over; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (Sore throat), PALPITATIONS (Heart starts pounding / Heart beating), CHEST PAIN (Chest hurts / Slight soreness in sternum area) and DYSPNOEA (Shortness of breath) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Anxiety, MULTIVITAMIN GUMMY BEARS for an unknown indication.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (Sore throat), PALPITATIONS (Heart starts pounding / Heart beating), CHEST PAIN (Chest hurts / Slight soreness in sternum area), DYSPNOEA (Shortness of breath), FEELING HOT (Hot / Felt very very hot), TREMOR (Arms are shaking uncountably), MYALGIA (Achy all over ) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Flu like symptoms, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (Sore throat), PALPITATIONS (Heart starts pounding / Heart beating), CHEST PAIN (Chest hurts / Slight soreness in sternum area), DYSPNOEA (Shortness of breath), FEELING HOT (Hot / Felt very very hot), TREMOR (Arms are shaking uncountably), MYALGIA (Achy all over ) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, Body temperature: 95 degrees fahrenheit (abnormal) 95 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated the event arms are shaking uncountably as not constant it comes and goes. Treatment drug Tylenol which patient took helped a little with the flu like symptoms.
Skin was red especially face, arms & chest. Body aches . Freezing to soaking wet sweating. Fever 100.2 up & down. Nausea & vomiting. Small Headache & now just muscle soreness & tired.
5- 11 YR OLD ORANGAGE CAP  COVID 19 VACCINE WAS GIVEN TO PATIENT INSTEAD OF 12 AND ABOVCOVID 19 VACCINE EVACCINE  GRAY CAP
Constant ache in the left arm with a shooting pain into the shoulder blade and down into her fingers, which is positional.  Activites such as removingher shirt and similar activity cause significant pain.
Injection site pain; Injection site reaction; Injection site swelling Information has been received from a health professional concerning a 50 year old white female registered nurse with sarcoidosis who on 04-JAN-2006 at 09:30 was vaccinated SC into the right arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot #651322/1044P). On 06-JAN-2006 at 08:30 the patient experienced tenderness, soreness, swelling at the injection site and a "ring" around the injection site )1-1 1/2 inches). Unspecified medical attention was sought. The patient was treated with (Keflex) 500 mg 4 times a day for 5 days. Subsequently the patient recovered. No product quality complaint was involved. Additional information is not expected.
22 hrs. after injection, on a Saturday 3/6/21, my husband suddenly felt chilled & shaky.  2 hrs. after that he felt nauscious & started a fever of 99 which climbed to 103 over the next 24 hrs.  He took Tylenol every 4-5 hrs. & stayed in bed. By Sunday his fever slowly started to go down.  And by the following  Mon. morning, 3/8/21, his fever was gone.  He felt weak but otherwise well enough to perform normal day-to-day activities/work.  12 days after that, on 3/20/21, he developed the exact same symptoms & went to bed immediately & took appropriate Tylenol.  His fever, this time, only went to just under 100.  He is scheduled for his second shot on 4/2/21.  Should he get it?  If not, what does he do???
Extrema, fatigue, dizziness, lightheaded, headache, nauseated. Loss of appetite, lots of pain at injection site, unable to get out of bed, malaise.
After receiving shot on Monday 11/6/23 at 4:00PM, soreness at the injection site became noticeable almost immediately. During the evening the pain got worse so I took some Motrin that got me to sleep. In the morning 11/7/23 I was dizzy and the pain in my arm was worse.  By the afternoon I was very tired and had to quit work. I went to work today 11/8/2023 but came home early as I started having significant chills and a runny nose. I checked my temperature and have a low grade 99.7 fever.
After having DTAP on 7/16/13 pt cried at least 3 hours of non-stop crying. Pt was fussy for 2-3 wks, per parent, after vaccines.
COVID VACCINE CLINIC, NO ADVERSE SYMPTOMS, WAITED 15 MIN WITH NO REACTIONS
gout on her feet; her feet were so sore; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GOUT (non-serious), outcome "unknown", described as "gout on her feet"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her feet were so sore".  Additional Information: The patient reported that she had to go into the cancer center in a wheel chair because her feet was sore. She also asked that if she could take hydrocodone/ acetaminophen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Irritation developed in vagina during the day April 28. A painful white sore/lesion was noticeable the morning of April 29. I immediately went to an urgent care clinic, where the nurse practitioner suspected and tested for herpes. I later read about patients presenting with herpes zoster after vaccination and asked her to test for that as well.  I began the prescribed Valacyclovir 500mg on May 3, and the lesion cleared by May 4. Both tests came back negative.
Dizziness; headache; body ache; extreme fatigue; mild soreness at vaccination site; fever; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via unknown route of administration at right arm on 09Mar2021 at 09:45 am (Batch/Lot Number: El3248) (age at vaccination 39-year-old) as dose 1, single for COVID-19 immunisation at workplace clinic. The patient was allergy to clindamycin. The patient received other vaccine on same date 09Mar2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications in two weeks. The patient medical history included asthma from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After 36 hours, the patient had began with mild symptoms after vaccine, dizziness, headache, body ache, extreme fatigue and mild soreness at vaccination site on 10Mar2021. Symptoms became progressively worse and fever developed 3-4 days after vaccine administered on Mar2021. The patient did not received any treatment for the events. The event mild soreness at vaccination site was resolved in 24-36 hours on Mar2021 and the outcome of the other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Flu vaccine administered 11 AM 10/30/03. Generalized itching approx 4 PM 10/30/03. Hives appeared that evening on posterior upper arms, trunk, buttocks, legs and waist area. Took Benadryl pills approx 8 PM 10/30/03. Hives reduced 10/31/03.
No additional AE reported; VAQTA that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a nurse, concerning a 66-year-old female patient. Information regarding the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.  On an unknown date, there was a temperature excursion of 71 Fahrenheit degrees, for 8 hours and 36 minutes, registered for hepatitis a vaccine, inactivated (VAQTA). It was reported that there was no previous temperature excursion.  On 03-NOV-2022, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, product quantity: 1, lot #W008110, has been verified to be a valid lot number for hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, expiration date: 27-OCT-2023 (dose, route of administration and anatomical location were not provided), administered for prophylaxis (product storage error).  There was no additional adverse event reported (no adverse event).
99 degree fever, chills, sweating, nauseated, coughing that caused vomiting, abdominal discomfort, fatigue, unable to keep food down for 1 week. Itching at injection site.
Within 24 hours I had an AVM stroke. Was near death for 2 days and was in hospital for over 2 weeks.
"Fever of 101, chills, hives ,long hot spells and a terrible headache"
2 prior first trimester miscarriages unrelated. 1 second trimester miscarriage  at 21weeks gestation in March 2021, normal weight and size at time of delivery. Vaccine was given 12/2020 and 1/2021
Pt vaccinated with DTP/OPV less than 2 min after injection anaphylaxis, 2nd episode 7-10 min after injection lasted 10 sec unconscious, fell, ridig, felt flexed, seizure which Dr described as sycopal episode.  See WORM for more details.
at 4/28/21 patient was vaccinated w/ Jessen vaccine and soon became pale and observed to became flaccid and pass out. pt's HR was 50, sat02 99% and BP 70/40. Pt soon observed with BLUE contracting and BLLE adducting followed by urine incontinence. Pt did not fall and was sitting in her chair the entire episode that lasted for approximately 40-60sec. Pt awake and continued to have hypotension, dizziness reported. EMS contacted and pt transferred to local ER for evaluation of suspected syncope and seizure s/p vaccination.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 60.85 for dose administered on 31-MAR-2021.  No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 31-MAR-2021 with temperature 33 degrees Fahrenheit from 12:00 PM to 01:00 PM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 35 degrees Fahrenheit from 01:00 PM to 02:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 31-03-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Pt vaccinated with DTP/HIB approx 5 hrs later pt unusually tired, lethargic, unresponsive, limp - mother called MD advised Tylenol 80MG & cool bath: Seen in MD office.