chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10p.m. Saturday, 2/20/21 until about 4 a.m. Sunday, 2/21/21, Chills, fever, shaking, nose cold and  teeth chattering from chills; Also on Sunday  fever of 101.6;  diarrhea about 10 a.m.  Monday, 2/22/21 and temperature of 100.6 Monday morning.
"Red, hot swollen size of dollar bill" 7x11 cm raised erythematous plaque on L anterior thigh.
Itching on various parts of the body occasionally throughout the day, including the palms, arms, legs, thighs, feet and back. Patient reported feeling small welts on the site of itchy skin when it occurs on the arms, back and thighs. This subsides after about an hour alongside the itching. Patient reported worsening of symptoms after taking showers.
COVID-19 breakthrough case. patient with 4 days of shortness of breath progressively worsening presented initially on 8/19 at the time was not hypoxic, was discharged with monitoring system. however shortness of breath has progressively worsened to severe, worse on attempted ambulation, associated with fevers, cough, generalized weakness, so came back to ER, noted to be requiring oxygen supplementation, and also short of breath on talking, so being admitted.  Admitted 8/22/21. Pfizer Covid-19 vaccine given on 3/24/21 & 4/14/21. Tested positive for covid on 8/19/21. Diagnosed and treated for acute hypoxic respiratory failure and covid viral pneumonia. Improved and discharged on 8/24/21.
3 days after recieveing dT patient with red swollen arm and hive-like reaction.  WEnt to ER and diagnosed with allergic reation to dT.  Given Benadryl/Prednisone. Per 60 day follow up, Pt recovered from adverse events.
In may 2021 I developed a extreme planter wart that will not go away and makes daily life very difficult. I had a blood test and was posit e for herpes
A non-serious spontaneous report of fever, cough and sore throat has been received from a nurse concerning a five-year-old female subsequent to H1N1, Intranasal. The patient's past medical history and concomitant medications were not reported. On 29-Oct-2009 the patient received H1N1, Intranasal. On 01-Nov-2009 the patient began to develop fever, cough and sore throat. The reporter stated the events were ongoing.
4cm X 5cm area of redness and induration with increased warmth at the site of injection. Unable to contact pt for confirmation of recovery after treatment.
Two days after the shot I started having pain in my middle finger on my left hand. It got worse as the days went on swelled and would not bend. It the. Was in majority of my fingers. NSAIDS were not helping. My neck and jaw as well. Fingers swelled double their size and would not bend or open all the way. Now is in my right ankle. Have a hard time doing my activities of daily living.
Administered vials after more than 30 days of refrigeration; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vials after more than 30 days of refrigeration) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vials after more than 30 days of refrigeration). At the time of the report, PRODUCT STORAGE ERROR (Administered vials after more than 30 days of refrigeration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided
FELT PRESSURE IN BOTH EYES / PRESSURE IN BACK OF EYES; LYMPH NODE SLIGHTLY RAISED; HEADACHE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, platelet low, and white cell count low. The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced felt pressure in both eyes / pressure in back of eyes. On 27-MAR-2021, the subject experienced lymph node slightly raised. On 27-MAR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) 100000, and White blood cell count (NR: not provided) Low (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 27-MAR-2021, and was recovering from felt pressure in both eyes / pressure in back of eyes, and lymph node slightly raised. This report was non-serious.
This spontaneous prospective pregnancy report was received from a nurse practitioner referring to a 23 year old pregnant female patient. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 01-MAY-2017, the pregnant patient with 26 weeks and 6 days (third trimester), was inadvertently vaccinated with a dose of M-M-R II that was reconstituted with sterile diluent,  therapy type HSA, (lot # M027637) for prophylaxis (dose, route, dose number and expiration date were not provided) instead of a dose ADACEL due to human error. No adverse effects were reported and no product quality complaint (PQC) was involved. The patient last menstrual period (LMP) was on 11-OCT-2016 and the estimated delivery date (EDD) was on 18-JUL-2017. At the time of reporting, the pregnancy outcome was pending. Additional information has been requested.
Information has been received from a pharmacy intern concerning a patient who on 10-DEC-2007 was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) "due to human error." The intern reported that the patient had no symptoms. Additional information has been requested.
Exposure date possible: 05/10/2022, and then again  05/12/2022, 05/12/2022 Nasal issues and congestion started to come about. and on the 05/14/2022 I started to get brain fog and began to feel out of it. Never had a fever or other symptoms. I felt tired prior however just normal fatigue that didn't seem abnormal. I did have a COVID-19 Test on Friday 05/13/2022 that was negative, and retested on 05/14/2022 Negative test again. I retested on Tuesday 05/17/2022 with a Positive result. I still have some nasal congestion and I am still testing positive as of 05/20/2022.
This spontaneous report as received from a Licensed Practical Nurse refers to a male patient of unknown age. On an unknown date the patient was vaccinated with Oka/Merck VARIVAX, (0.5 ml; route, dose number and lot number unknown). It was reported that the patient passed out after receiving Oka/Merck VARIVAX. The outcome of the patient passed out was considered to be medically significant. Additional information is not expected because there is no permission to contact physician.
Temp 100.9 fir two days, chills, nausea and body aches
Swollen red circle on skin at injection site, over 1" in diameter, extremely painful to touch (shirt sleeve or bedsheet laying against it caused extreme pain). Redness felt hot to the touch. Pain started to lessen by the 23rd, swelling and heat started going down by the 24th, then became itchy. Still slightly red and skin feels slightly rough as of the 26th.
on april 13th i started having abdomen pain....thought it was indegesstion or constapation!  as each day went on the pain kept getting worse by just abit..so on april 8th i recieved the first moderna vaccine shot...on the 13th i started feeling abdomen pain.. ON APRIL 18TH I WAS TAKEN TO HOSPITAL IN A WHOLE LOTTA PAIN!   They took my blood and urine for tests...then took me for a cat scan of the abdomen and found i had appendicitis and it had to be taken out immeadiatly!! I was released from hospital on the night of april 19th and told not to go to work until im released by surgeon. im still in alot of pain cause of the inflamtion and infection in the abdomen! and also missing work!
flublok was frozen and placed in the door of the fridge; the lowest temperature reached 33 f or it may have been slightly below that; the total excursion lasted 18 hours; administered to a patient with no reported adverse event; flublok was frozen and placed in the door of the fridge; the lowest temperature reached 33 f or it may have been slightly below that; the total excursion lasted 18 hours; administered to a patient with no reported adverse event; Initial information received 10-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient and reporter reported that flublok was frozen and placed in the door of the fridge; the lowest temperature reached 33 f or it may have been slightly below that; the total excursion lasted 18 hours; administered to a patient with no reported adverse event while receiving vaccine influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrivalent recombinant (with an unknown strength, formulation, dose, frequency, route, expiry date, batch number, administration site) for influenza.  On an unknown date the flublok was frozen and placed in the door of the fridge; the lowest temperature reached 33 f or it may have been slightly below that; the total excursion lasted 18 hours with no reported adverse event (product storage error) and administered to a patient with no reported adverse event(poor quality product administered) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  No lab data reported.  Action taken was not applicable.   At time of reporting, the outcome was Unknown for both the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vial initially stored on 31-JAN-2022 and then administered on 26-May-2022; The patient received dose after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 26-May-2022) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2022 at 12:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-May-2022 at 12:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 26-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 26-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had received 1 booster dose.  It was reported that the HCP administered the vaccine after the beyond use date, as the HCP didn't know that the vials shouldn't be used past 30 days from thawing the vials. Vials were initially stored on 31-Jan-2022. Thaw expiration date was 02-Mar-2022. The vial did not undergo any temperature excursion.  No treatment medications were reported.
Pt recvd 1st dose of Hep B vax w/no adverse rxn; pt recvd 2nd dose & exp burning & twitching in cheek;
general pain in the arm for the first 2 to 3 days feeling of being unwell started 6 days after injection date.   no fever.  just a feeling of general fatigue that lasted for 2 to 3 days
After receiving Trumenba IM around 4:30 PM,  Patient felt very tired and went to sleep.  Awoke at 3AM on 8/1/19, drank water then back to sleep.  When she woke up around 8:00am and was in the bathroom she became lightheaded and passed out and fell.  No identified injury. Seen at PCP office 8/1 by Dr - diagnosed with dehydration.  Pt reported she was feeling better after appointment and hydrating.
I developed a very rare autoimmune disease called bullis pemphigoid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PEMPHIGOID (medically significant), outcome "unknown", described as "I developed a very rare autoimmune disease called bullis pemphigoid".   Clinical course: Patient received the Pfizer vaccination for coronavirus in fall of last year. After receiving the vaccination, she developed a very rare autoimmune disease called bullis pemphigoid. The medications and treatments are very expensive. Her doctors attribute her disability that was very rare for a healthy 40-year-old mother of two to develop as a result of the vaccinations received through Pfizer.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I was very itchy and noticed my hair volume had decreased. I received treatment from a dermatologist; I was told my gluten levels were high.
Dry mouth; Raspy Throat; Cough; Fever of 99; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Raspy Throat) and COUGH (Cough) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced DYSPHONIA (Raspy Throat) and COUGH (Cough). At the time of the report, DYSPHONIA (Raspy Throat) and COUGH (Cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
sore arm lasted about 10 days Muscle cramps from knee to thigh lasted about 2 or so weeks off and on vertigo/dizziness lasted about 3 weeks
My left knee began to feel swollen. The next day, I noticed the upper right back became achy. That continued and I developed a rash on the 22nd of April. The rash was on my upper back and progressed to my sides and upper abdomen. I was seen at urgent care and said she was diagnosed with Shingles.
COVID-19 INFECTION; SUSPECTED VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned a 33 year old male of unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, route of administration was not reported, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 01 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, it was reported that, "the patient died due to coronavirus disease-19 (covid-19), even though he was vaccinated (suspected vaccination failure)". It was unknown if autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event covid-19 was fatal and outcome of the suspected vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000207040.; Sender's Comments: V0. 20211232923-covid-19 vaccine ad26.cov2.s -Died of Covid 19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211232923-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID-19 INFECTION
Information has been received from a RN concerning a 48 yr old female with asthma and allergies to aspirin and ibuprofen (Advil) who on 31Jan06 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). The same day, the pt experienced pain and swelling in the injection site arm. She went to the ER, but it was unk what treatment the pt received. On 03Feb06, the pt recovered. The nurse requested a lot check be performed on this lot since she was concerned about using it again. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill.  Additional information has been requested.
9PM rt arm noticed to be red, swollen & warm to touch @ inject site; given APAP & attempted to settle down for noc; restless & c/o pain; 4AUG92 mom noticed arm redder & more swollen; called clinic; MD felt w/o abscess just local rxn to DTP;
Fever over 101 at night for > 1 week, elevated heart rate, chest pain, shortness of breath onset 12/22/2021 1 AM.
Headache, Myalgia, chills Narrative: Per nursing report: "2nd dose COVID 19 vaccine on 4/7/2021 - called this morning [4/8] with symptoms of headache, chills and body aches"  Other Relevant History:
vaccine was 30 days expired; COPD; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 95-year-old male patient received pneumococcal 20-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 20), on 03Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "vaccine was 30 days expired"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD". Additional information: The reporter stated she is a nurse calling on behalf of her 95 years old dad. The reporter received a call from the pharmacist stating they did not realize the vaccine was 30 days expired. The reporter stated this is frustrating how a pharmacy can keep a 30 day expired medicine on the shelf. Her dad (patient) has COPD.   The information on the batch/lot number for pneumococcal 20-valent conjugated vaccine (diphtheria crm197 protein), pneumococcal 20-valent conjugated vaccine (diphtheria crm197 protein)  has been requested and will be submitted if and when received.
Received PNEUMOVAX 23 8-18-15 2pm - noticed evening swelling of arm, tenderness H/A, fever 101.
little bit achiness; little bit sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (little bit achiness) and PAIN IN EXTREMITY (little bit sore arm) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (little bit achiness) and PAIN IN EXTREMITY (little bit sore arm). At the time of the report, PAIN (little bit achiness) and PAIN IN EXTREMITY (little bit sore arm) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reporter. The patient received the Moderna Bivalent Booster dose last evening. On an unknown date in Sep-2022, the patient had a little bit sore arm and a little bit achiness. No treatment medications was reporter.
Client added 2/16/07 to report she had child and no fever 2 wks after having Iz-Zostavax-then developed spots on ankle right and continued to have rash over sternum, head, torso and some on extremities-spoke with client 2/01/07 and rash has crusted over. Did not see her PMD-still feel she has decreased energy today.  States she had a mild case od chickenpox as a child and had a positive titer done in the 1960's.
Day 7 notes slight "rash" but unsure it was issue Day 8 ( Friday)  maybe slightly more- did not itch- didn't pay much attention Day 9 -trunk to breasts (no back) - small red bumps- on tummy appears as large red areas - larger bumps both legs- slightly less on both arms- they do get small and red near ankles- tried benadryl oral - no change Day 10- as above- tried witch hazel only some spots- 2% hydrocortisone cream only some pots and combo some sport- noted no change Day 11 ( 3/22)  as above- no real change
04/26 swelling and redness, tennis ball circumference per mother. 04/27 Seen in office, swelling resolved, reddened area 9cm x 5cm from injection site (left thigh) to inner aspect of thigh. Resolving as of 04/27.
Headache x 20 minutes. Left posterior pharynx felt dry and itchy. Generalized itching without hives
Initial information received from a healthcare professional on 05 October 2012. A 70-year-old female patient, whose medical history included none and concomitant medication were not reported, received intramuscular FLUZONE HD (Lot number U4498BA, Expiry date 16 April 2013) in right deltoid on 05 October 2012. The report stated that, the patient had arm swelling immediately post vaccination on 05 October 2012. Laboratory details and treatment were not reported. The patient did not seek medical attention for either complaint. The patient's outcome was unknown. Documents held by sender: None.
Achy muscles and exhaustion off & on for 4 weeks and continuing to  this day. Peaked Oct 23-29 with severe flu-like symptoms but no fever.
0.5mm area at injection site where the top layer of the skin appears to have been scratched off. 3.5mm x 4.0mm red, warm to touch area circled with a pen by patient's mother when she first noticed the reaction at approx 6:30 pm on 6/18/2020.  Mother states she gave the child benadryl at approx 6:30pm. Mother states child c/o mild pain at the site and itching. 6.0mm x 7.5mm red, warm to touch area circled by mother with pen at approx 11:00am 6/19/2020. Child denies pain while in clinic today @ 2:00pm 6/19/2020 for us to look at the reaction.