chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEALTH FAILING; GETTING SICKER BY THE DAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced health failing, and getting sicker by the day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the health failing and getting sicker by the day was not reported. This report was non-serious.
came in on 10/16/2020 with redness and swelling below injection stie came back on 10/17/2020 with extended redness and swelling down left arm  pt called md and left message pt went to urgent care on 10/17/2020 and was told infected, given antibiotic
24 hours after shot, began feeling a little light headed while bike riding. Symptoms worsened around day 8, especially after climbing stairs or walking quickly immediately after sitting or lying down. Felt dizzy, with a headrush and slight jolt of adrenaline afterwards. Lasted a few minutes, then was able to resume normal activity. 21 April, day 9, dizzy spells seemed to occur more easily and frequently. 22 April felt better.
Pt developed purpura, new lesions for 4 days with some edema of hands; no renal involvement, resolved completely with in 2 weeks.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (BAD REACTION) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (BAD REACTION). At the time of the report, VACCINATION COMPLICATION (BAD REACTION) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was reported. Reporter did not allow further contact
pain, burning, frequency with urination, large blood clots in urine on October 30th, ended up having kidney stone
3-4 hours after vaccine sore throat and sinus congestion through night, lungs felt hard to breathe. 4 days after bad cough with thick mucus.
A non-serious spontaneous report of severe joint pain has been received from a consumer concerning an 18-year-old female, subsequent to FLUMIST. The patient reported no past medical history. Concomitant medications include GARDASIL. The patient received FLUMIST on 26-Sep-2009. On 28-Sep-2009, the patient experienced severe joint pain in her fingers, toes, knees, neck pain, and muscle tightness around her chest and back. On 28-Sep-2009, after consultation with her pediatrician, who suggested the possibility of Guillain-Barre Syndrome, the patient went to an urgent care facility for observation and Guillain-Barre Syndrome was ruled out. The patient received her second dose of GARDASIL the same day as FLUMIST. The outcome of the event of severe joint pain was recovering. Causality was not reported.
This spontaneous report as received from a male consumer of unknown age refers to himself. The patient stated that he has "just received" a booster for an unspecified pneumonia vaccine that protected against 23 or 24 serotypes of the virus (manufacturer unknown) (lot # not reported). The patient mentioned that he had had a 102 temperature at an unspecified time that resulted in him developing pneumonia. The patient did not confirm if he received the booster dose of this vaccine before or after he developed the pneumonia, nor did he explain when his initial dosing with the vaccine series began. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
swelling & redness of both lower extremities from waist down;burning sensation on lt side of neck & diff swallowing;
No additional adverse effect; A patient was administered a dose of improperly stored GARDASIL 9; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were not reported.   On 23-JUN-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular route, lot # 1621929, expiration date on 06-DEC-2021 as prophylaxis (strength, dose, frequency, and anatomical location were not reported). No additional adverse effect was reported.   The administered dose of vaccine experienced the temperature excursion below 36 degrees Fahrenheit (30.3 degrees Fahrenheit) for 15 minutes. The previous temperature excursion was above 47 degrees Fahrenheit (54.6 degrees Fahrenheit) for 1 hour. 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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1621929; expirationdate: 06-DEC-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
Bells palsy; This is a spontaneous report from a contactable Other Healthcare Professional (patient) reported for herself. A 29-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Feb2021 at single dose for covid-19 immunization. Medical history included allergies to sulfa, covid-19, prior to vaccination, the patient was diagnosed with COVID-19 (test positive). The patient's concomitant medications were none, the patient didn't receive any other medications within 2 weeks of vaccination and didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 on 25Jan2021 15:30 at 28 years old for covid-19 immunization. The patient experienced bells palsy on 13Mar2021. Therapeutic measures were taken as a result of bells palsy included steriods. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.  Follow-up attempts are completed. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's Palsy cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pregnancy Registry (Pregnant and received vaccine); This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy Registry (Pregnant and received vaccine)) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use on 31-Oct-2020, Pregnancy (Live - full term birth) on 13-Nov-2018 and Complication of delivery (Past-due and low-amniotic fluid led to labor induction, high blood pressure) on 13-Nov-2018. Concurrent medical conditions included Seasonal allergy, Allergic asthma and Gluten sensitivity. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Seasonal allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Vitamin supplementation.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 09-Oct-2020 and the estimated date of delivery was 13-Jul-2021. On 28-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy Registry (Pregnant and received vaccine)). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 28-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy Registry (Pregnant and received vaccine)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound foetal: normal (normal) 172 heart rate at 7 weeks..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.  The estimated date of conception was reported as 31-Oct-2020. The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy.
1 day post injection, pain in lungs on the backside of the  lower back.  Left arm felt like punched.  2nd day post injection - fatigue, body aches.  Pain in arm went away. No mark, redness, or soreness at injection site - arm flat, no pain. 1 week post injection - sudden raised, itchy, physically hot rash at injection site, painful to the touch.  Lump below skin and visible rash about 2 inches around.
For 2 days, typical arm soreness, flu-like symptoms with significant muscle pain and general weakness and malaise. However, on the 5th day, EXTREME abdominal pain, left side. Pain level up to 9. Incapacitating. Two visits to urgent care. This was in March before any info came out about adverse blood clot events for the J&J vaccine, so the doctors were not really interested at the time that I had just gotten my shot. They gave me antibiotics, thinking it may be diverticulitis (diagnosis based on symptoms only - no diagnostics - it was the doctor's "best guess"). Pain did not subside, only got worse. 4 days later I could barely move, abdominal pain was extreme. Went back to clinic and they did a PET scan to check for diverticulitis. There was none; PET scan revealed nothing out of the ordinary. So they told me they had no idea what it was and sent me home. PET scan reading by the doctor notes specifically that blood/vascular was not able to be observed because no contrast or dyes were used. Bottom line was over 10 days of extreme abdominal pain 5 days after receiving the shot. I've never experienced anything like that before.
Excessive thirst 15mins post  Heart palpation with fluttering sensations 30mins post HTN 156/96, 80hr, 1hour post  Chills 1hour post  Muscle spasms with cramping throughout body 45mins post Muscle weakness to left side 2hour post Facial twitches Treated with tylenol and Gatorade and rest. Symptoms lasted 48hours post.
w/in 6-8 hr p/vax pt devel an inj site rxn w/redness, swelling, warmth & pain;pt seen by MD 1 days post vax;MD dx cellulitis & tx w/DPH & ice;
Improper storage of product in use; No additional adverse effect reported, no further information provided; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 30-DEC-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (Lot# U015680 and expiration date 18-MAY-2023) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius (minus 13.6 Celsius) for 0 hours 45 minutes and 0 seconds and minus 14 degree Celsius to minus 10 degree Celsius (minus 13.5 Celsius) for 0 hours 45 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided. This is one of 8 reports from the same reporter.
Red warm area (L) upper arm-tender. Duricef 500/5 1 tsp Bid x 10 days.
My initial symptoms were a headache, scratchy throat, congestion, and a fever that never went above 100.1. I also did have a little bit of a rash on my chest that looked like Shingles on 01/08/2023. I started to take Valtrex but it did go away quickly. I did have a virtual visit with my physician and she prescribed Paxlovid. I never got any sicker than that. My fever never went up and my cough was manageable. I was very tired and slept a bunch. I tested negative, then a couple of days later, I felt like I was getting a cold. We tested positive today and it seems to be a rebound case. Now I have a runny nose. I do feel warm and tired and I do have an occasional cough.
Patient with swelling and redness at injection site (Left arm) did not want to use her arm 2" x 1.5 " induration.
Case completed primary Covid vaccine and one booster as of October2021, then was hospitalized for Covid in May 2022. Hospitalized at:  Hospital. Pneumonia due to COVID-19 virus Presented with 7-10 days of cough, one day of fever and shortness of breath. Chest x-ray revealed bilateral ground glass opacities. Tested positive for Covid-19. Vaccinated x 3. Hypoxic to 80s at time of admission, corrected with 2 lpm to low 90s. He was out of window for dexamethasone based on reported onset of cough more than a week prior to admission (and there is little evidence this provides significant benefit for hospitalized patients) and so was treated with dexamethasone 6 mg daily. Asked to finish course at home. He is back on room air at time of discharge.
This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 63-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included back disorder and bladder cancer. On 17th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pneumonia (serious criteria GSK medically significant), chest infection (serious criteria GSK medically significant) and product supply issue. On an unknown date, the outcome of the pneumonia was recovered/resolved and the outcome of the chest infection was not recovered/not resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the pneumonia and chest infection to be related to SHINGRIX. Additional information received as follows: Three months before reporting date, the patient experienced pneumonia for which he was treated and has resolved. Approximately one month before reporting date, he was diagnosed with a chest infection outside of his lungs for which he was currently being treated and it had not resolved. The patient had been unable to find second dose of SHINGRIX and was now outside of 6 month window for second dose. The reporter gave consent to follow up. The contact details of the physician were provided.
Patient was injected with 0.2ml of  Covid-19 pediatric vaccine.  Patient turned away and small amount of vaccine ran out.
Pt. called health director and reported limited range of motion to (R) arm after receiving flu vaccine.
I was diagnosed with idiomatic trombocytopenia in August, one day after my non-blood related nephew received the same diagnosis for very low platelets requiring transfusions.  Mine were found incidentally wen bloodwork was done before an ablation for SVT, with numbers at 95, 78 and 87 over a 24 hour period.  I am not having significant bleeding issues or symptoms.  As both of us received the Pfizer vaccine and I usually have normal bloodwork and am generally quite healthy, I question whether the low platelets are the result of the vaccine.  I found an article  possibly linking this in 3 severe cases.
Right after vaccination patient states she felt a lot of arm pain. She went home and moved arm around however days passed and arm got worse and now she states she is unable to lift arm and unable to sleep due to pain
Fainting (few seconds), pale, sweating, shallow breathing, low blood pressure. Patient was  awake and responding to questions. By the time ambulance arrived, patient was able to walk. Patient contacted last night and he was completely fine.
Nausea; Chills; Hot body (Temperature Unknown); Very Bad Headache; Rash and two bumps on the left side of Neck; Sore Arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), FEELING HOT (Hot body (Temperature Unknown)), RASH (Rash and two bumps on the left side of Neck), HEADACHE (Very Bad Headache) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 26-Feb-2021, the patient experienced RASH (Rash and two bumps on the left side of Neck). On 27-Feb-2021, the patient experienced HEADACHE (Very Bad Headache). On 01-Mar-2021, the patient experienced FEELING HOT (Hot body (Temperature Unknown)) and CHILLS (Chills). On 02-Mar-2021, the patient experienced NAUSEA (Nausea). On 24-Feb-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. On 27-Feb-2021, RASH (Rash and two bumps on the left side of Neck) and HEADACHE (Very Bad Headache) had resolved. At the time of the report, FEELING HOT (Hot body (Temperature Unknown)), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Tylenol Orally, Benadrly orally.
Signs of nausea 3 - 4 min after mist he c/o dizziness, became pale, diaphoretic. Placed on floor with legs above heart x 5 min, cool cloths applied. Wheeled to health room sat - rested x 10 min, skin warm, dry. Taking fluids, HR 90, dizziness, nausea resolved. (Mother reports fever after first dose when contacted).
Aches; headaches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain (Verbatim: Aches) and headache (Verbatim: headaches).The outcome of the pain and headache were resolved.   It was unknown if the reporter considered the pain and headache to be related to RSV vaccine.   It was unknown if the company considered the pain and headache to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 28-SEP-2023 This case was reported by a patient via interactive digital media. The reporter stated that RSV shot put him/her down for 2 and half days. The patient experienced aches and headaches but now just fine. The reporter stated that he/she would do it again to not get the SRV. The follow up would not possible as no contact details were available.
This spontaneous case reported by a consumer, describes the occurrence of hypoesthesia (I have numbness in my arm & leg on left-side) in a  patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced hypoesthesia (I have numbness in my arm & leg on left-side). At the time of the report, hypoesthesia (I have numbness in my arm & leg on left-side): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications and treatment information not provided.
The current episode started 11/13/18 (Patient received the pneumococcal 23 vaccine in her left upper arm) Few hours later she noticed redness, swelling and pain. Patient was seen in the office on 11/14/18, and the redness had spread down into her elbow and there was tenderness. The problem had been rapidly worsening since onset. The affected locations include the left arm (left upper arm and spreading down into elbow). The rash was characterized by pain, redness and swelling. Associated with: Pneumococcal 23 vaccine. Associated symptoms include a fever. Patient tried ice and TYLENOL, which were mildly effective. Patient started on KEFLEX and Prednisone, as well as TYLENOL and BENADRYL as needed.
Day after- severely tired and headache. Beginning  day after and continuing 2 days after- redness, swelling, hard area around injection site.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No patients' medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patients were vaccinated with a dose of RECOMBIVAX HB lot number: K010216, expiration date: 17-SEP-2016 (thimerosal status not provided), lot number: L014419, expiration date: 15-APR-2017 (thimerosal status  not provided), lot number: J013394, expiration date: 25-AUG-2016 (thimerosal status not provided) (dates, doses and routes not reported), that were improperly stored. The vaccine was stored in temperature in 1.7 Celsius degree (C) for two hours and 5 minutes and in 1.7 C for 2 hours and 15 minutes. There was no previous temperature excursion. The excursion was captured with the use of Digital Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as the nurse did not wish to be contacted.
Patient developed low grade fever and swelling, erythema and warmth at the injection site. Swelling progressed to about 12 cm area, then began decreasing in size.