chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a female patient of unknown age. On unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported, formulation also reported as "inhaler"). No other co-suspects were reported. No concomitant medications were reported. It was reported that about a month ago (in approximately September of 2012), while on PNEUMOVAX 23 the patient's arm became very swollen. No treatment information was reported. It was reported that the patient sought unspecified medical attention. At the time of report, the outcome of the patient's event was unknown. The relatedness for the patient's event was not reported for PNEUMOVAX 23. Additional information is not expected.
Patient developed petechial rash of legs &trunk after 2nd COVID vaccine on 03/09/2021. Saw 2 different dermatologists who gave steroid cream with some effect. They did not think biopsy needed. after COVID Booster 12/28/21 rash recurred petechial and  worse than before. Consistent with allergic vasculitis
While in observation area, patient reported to EMT a rash and itchiness in abdominal area. EMT notified lead nurse on site. EMT assessed patient and reported blood pressure 142/90 mmHg, regular pulse 60 bpm, and respirations 16 breaths per minute. Patient denied difficulty breathing, difficulty swallowing, and chest pain. Patient revealed history of allergies to unspecified medications. Patient offered diphendyramine. Patient refused diphenhydramine. Patient advised to wait 15 minutes for further observation. Lead nurse assessed patient. Patient reported decreased itchiness and denied difficulty breathing, difficulty swallowing, and chest pain. Patient advised to seek emergency care if symptoms progress. Patient left observation area with steady gait.
Dizziness the evening of the vaccine. Dizzy when head turns. Still some dizziness now (5 days later). 2 days after vaccine noticed slightly raised skin and redness radiating from the injection site. A red circle about 2.5 cm in diameter at the site, 2 elongated red ovals 7 cm long and 1.5 cm wide going from near the injection site towards the underarm, another 1 cm in diameter circle at the end of one of the ovals. Started taking antibiotics 2 days after vaccination in case this was an infection (Doxycycline Monohydrate 100mg twice a day). 5 days later redness has decreased but can still be seen. No new spots or growth of existing ones.
Left arm swelled and was sore. I took ibuprofen, applied a heating pad.
10:50 am Student shaky, dizzy, no breakfast - given juice - BP 110/76. 11:00 am - pale, dizzy, lied down BP 120/72 pulse strong. 11:10 am - O2 applied 4L per mask Denies SOB or throat tightness. 11:15 am - cheeks pink, slight tremors noted arms/legs, still dizzy. Parent called - requested 911. 11:20 am Slight tremors, "spinning" feeling continues 118/64 pulse 82. 11:25 EMS - took to ER there rash noted on trunk - treated with BENADRYL and Prednisone.
Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 22-MAR-2021, the patient was vaccinated with one Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) vial (lot number T024557, which has been verified to be valid, the expiration date was reported and validated as 15-MAR-2022), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001297:
Dizzy, nausea, headache, very sore legs and hands, chills, fever., fatigue.  The headache was the last to go, it lasted for 2 days.
Feeling uneasy; Nausea; Chills; General fatigue; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Feeling uneasy), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (General fatigue) and PYREXIA (Fever) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced MALAISE (Feeling uneasy), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (General fatigue) and PYREXIA (Fever). On 10-Jan-2021, MALAISE (Feeling uneasy), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (General fatigue) and PYREXIA (Fever) had resolved.      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.   Concomitant product use was not provided by the reporter. Treatment medications included paracetamol and ibuprofen.   This case was linked to MOD-2021-004601 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
difficulty breathing, pale, rash on chest ,diaphoretic   treated with diphenhydramine inj and dexamethasone injection
Large - 2" diameter - rash at injection site: itchy, hot, slightly raised. Treated with ice, benadryl - not terribly effective. Rash mostly subsided as of this date (7 Nov) - still slightly itchy and visible Low grade, persistent fever 99.3-101.3 (on-going as of this submission - 7 Nov) Joint pain, muscle aches. Treated with Aleve - symptoms subsided Dizziness - 48 hour duration, mild
Contracted covid after getting the vaccine; Contracted covid after getting the vaccine; This is a spontaneous report from a Pfizer Sponsored Program. A contactable physician reported similar events for 4 patients. This is 2nd of 4 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced contracted covid after getting the vaccine on an unspecified date. The report was non-serious per the reporter. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: The association between the event lack of effect (contracted COVID) with BNT162b2 can not be completely excluded.,Linked Report(s) : US-PFIZER INC-2021003873 same reporter/drug/event, different patient
I had seizures as a child but was not diagnosed. In 2018, I had two seizures, but was diagnosed and have been on 100mg zonisamide for 2.5 years with no episodes. In 2014, I had a bad fever during an infection, and may have seized while sleeping. Not sure. In my adult life, I have received annual flu shots every year, and twice developed fevers as a side effect. After Moderna #2, I woke at 1:30am at my apartment with chills and fever. Took 2 acetaminophen and used the bathroom. I seized before I could take my temp. Upon reviving, I noted that about 15 minutes had elapsed since I first woke, so this seizure lasted under 10 minutes. I had a bruise on the back of my head, and later developed some bruising on the front of my thigh from the fall. I followed the protocol that my neurologist has established for me: called my sister for a ride to ER for evaluation. After several tests, I was released to my sister's care. Precautions we took for the next 24 hrs at sister's home: take temp every 2-3 hours to watch for fever, take acetaminophen every 6 hours. I'm fine now.
On 9/4/07 Tdap and Hep B vaccines given in left deltoid. On 9/13/07 the patient's husband called and reported that patient was unable to move left arm and had an appointment with a specialist. No further information available.
her lungs looked scarred on both sides.; partial collapsing in the bottom and upper lung known as atelectasis; she had sharp pains in her chest, back, and in different parts of her body.; she had sharp pains in her chest, back, and in different parts of her body.; she had sharp pains in her chest, back, and in different parts of her body.; headaches; a blood spot" on her arm near the injection site, described as a "blood circle."; ashortness of breath; redness around her nose, eyes; redness around her nose, eyes; pain in her eyes; her lungs looked scarred on both sides. Caller states that "one doctor felt like a nodule, but another doctor didn't feel it."; inflammation; This is a spontaneous report from a contactable consumer (the patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included rare lung disease, in which her right lung is attached to her rib cage. The patient's concomitant medications were not reported. Caller stated that she was having a hard time finding a place that would administer the second dose to her. She did not want to go back to the original site. Caller was worried about receiving left over Pfizer Covid-19 vaccines from an original site. Caller stated that the vaccine was being stored in a refrigerator around "7 degrees" but she wasn't sure that is a guaranteed temperature. Caller received the first dose of the Pfizer Covid-19 vaccine and stated that she had sharp pains in her chest, back, and in different parts of her body. She also had headaches, "a blood spot" on her arm near/under the injection site, described as a "blood circle." She experienced shortness of breath, redness around her nose, eyes, and pain in her eyes. She went to the emergency room/ hospital three times within three months. She just went to the ER, she was never admitted. A doctor said her lungs looked scarred on both sides. Caller stated that "one doctor felt like a nodule, but another doctor didn't feel it." She was told she had partial collapsing in the bottom and upper lung known as atelectasis. She was "high risk due to a pre-existing rare lung disease, in which her right lung is attached to her rib cage." Caller asked if her reactions have been reported, caller asked if any rare reactions have been reported, Caller asked if her reaction would be considered an allergic reaction or hypersensitivity reaction, Caller asked if any ingredient of the vaccine would produce inflammation or pain that she has experienced. Caller stated the leaflet on some medications states to not take the vaccine or any vaccines while taking the medication. Caller asked, "Can you be on certain medications that may react with the vaccine?" Caller was referring to any antibiotics and prednisone. Caller also asked if the Covid virus was always present with a fever. The outcome of the events was unknown.  Information on lot/batch number has been requested.
That same evening, I felt like my immune system was compromised. I was 100% and felt lethargic. The next day I got a fever blister on my lower lip. I hadn?t had a fever blister in years. I began applying medicine and the fever blister persisted and was larger than I recall having before. Also it took much longer to heal (approx a wk and a half).  Starting on 02/16 the severe weather resulted in power/water outages. My house was very cold and I just wanted to sleep under the covers.  I continued to feel tired most of the week, but I don?t know if related to a reaction to vaccine or due to the cold.  Additionally I?ve had one yeast infection in my lifetime and now I feel it coming on again and it makes me wonder if my immune system was really compromised after the Moderna vaccine.  I?m not sure, but thought best to report. These are not life-treatening symptoms. Thank you
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 55-year-old white and non-Hispanic or Latino male. Initial information received from patient on 02-JUN-2021 was processed with additional information received on 03-JUN-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to sulfa. Patient was non-alcohol user, and non-smoker. Patient had no any history of drug abuse or illicit drug use.  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,1 total, administered on 13-MAR-2021 to right arm as prophylactic vaccination. No concomitant medications were reported.  On14-MAY-2021, the patient went to doctor for a regular antibody test and also completed a spike protein test. The antibody test was negative (confirmed immunological vaccine failure). The result of spike protein test was negative. On 26-MAY-2021, the patient had T-cell test and antibody test. Both tests were negative. Laboratory data included: Antibody test (NR: not provided) as Negative, and SARS-CoV-2 IgG antibody test (NR: not provided) as negative. On 26-MAY-2021, Laboratory data included: Antibody test (NR: not provided) as Negative, and T-lymphocyte count (NR: not provided) as Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000181572.; Sender's Comments: V0:20210606012-COVID-19 VACCCINE AD26.COV2.S-Confirmed immunological vaccine 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
got the shot and got the shingles /suspected vaccination failure; shingles; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not reported. The reporter stated that, his wife got the shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Patient had DTaP yesterday, complaint of a high pitched scream last night. Patient's temperature was as high as 103.9. Patient "shaky" per mom and irritable. Tylenol and comfort measures given.
In the 12 hours following the vaccine, he was drowsy and somewhat lethargic - he developed a low-grade fever approximately 12 hours later and became extremely fussy. He has been uncontrollably crying off and on and acting in pain since 12 hours after the vaccination and has been unable to sleep more than 20 minutes at time over the last 48 hours.
Red rash, itching day 2 and 3  (1/15 and 1/16) Red rash, itching, and swelling 1/20, 1/21, 1,22 continuing. Swelling is getting hard and worse
Fever 101.7 - chills - malaise Starting approximately 18 hours after injection. Lasting approximately 24 hours.   Multiple (5+) herpes sores on upper and lower lips and surrounding face. Started 02/09/21 and still ongoing.
Approx one week after receiving smallpox vaccine pt noted swelling on both sides of neck. Pt then noticed in Sept 06 that left eye was swollen and not opening all the way and left side of face slightly swollen.
RED ARM; SWOLLEN ARM; SORE ARM; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid positive. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, expiry: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced red arm. On 06-APR-2021, the subject experienced swollen arm. On 06-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, red arm, and swollen arm. This report was non-serious.
mom reports pt very red & swollen w/dark areas;pt seen @ hlth dept 14MAY;mod swelling, redness & inc warmth thighs bilat;mom reports pt cried non-stop from 2AM-630AM on 14MAY98;was inconsolable;low temp;appear well x/local rxn;
Began with low grade fever and chills. Monday morning I awoke with low grade fever, arm and neck pain, headache and fatigue. Chills developed throughout the day, arm and neck pain and severe headache with nausea and I was unable to work. Continued with fever and chills until Tuesday morning.  Fever subsided but still felt cold all day.  Able to work minimally on Tuesday and then severe headache, chills and fatigue Tuesday evening.  Symptoms only minimal on Wednesday and Thursday (headache and pain at injection site).
Information has been received from a consumer concerning about her currently 20 year old daughter with yeast infection and none drug reactions who in approximately January 2012, was vaccinated during doctor office visit (for yeast infection) with a dose of GARDASIL, (dose, number of prior doses, route and Lot # unknown). In approximately January 2012 (in the moment of vaccination) patient underwent unspecified pregnancy test and unspecified sexually transmitted disease (STD) test were both negative. In approximately January 2012 (reported as "one week later"), her Papanicolaou smear (PAP) was off. Two weeks after receiving GARDASIL a colposcopy was done and was negative but the scraping was positive for possible cancer. The patient did not seek medical attention. No treatment was given for adverse events. At the time of the report the patient status was unknown. Upon internal review, Scraping was positive for possible cancer was determined to be an other important medical event. Additional information is not expected.
Night of vaccine (4/6) experienced: chills, slight soreness in injection arm, nausea, burning lips, numbness of tongue, scratchy throat, swollen lips and tingling sensation on face, primarily left side above upper lip, legs and arms (paresthesia), extreme tiredness.  This persisted, though did get a bit milder over the course of the next few days.  (4/11-12) Sensation of tingling persisted and seemed worse throughout body primarily at night, lips continued to feel "burnt" and sore.  (4/13) Spoke with my Dr about issues and was told I had an intense response to the vaccine and she would get the opinion of an allergist/immunologist as to whether this was an allergic reaction.  (4/15) Tongue finally felt normal.  Paranesthesia persisted primarily at night. (4/30)  Headache, nausea and paranesthesia with both small toes on both feet feeling numb all day.  At night paresthesia intensified in head area and pressure in head developed. (5/1) Went to urgent care after several phone conversations with nurses.  EKS and blood work performed and urgent card Dr noted rare adverse reaction to vaccine.
1st night: Injection arm sore and "heavy", much like a tetanus shot.  This was expected.  2nd night:  BOTH arms sore (didn't make sense). Then got very tired and lethargic around 7pm. Temp at 8pm was 100 deg. Took Tylenol.  Muscle aches and runny nose around 8:30. Gave up and went to bed.  Woke up at 3 am, fever had broken , but didn't take temp. Fell back to sleep.  Ended up sleeping 11 hours.
Rotavirus vaccine given IM instead of po on 10-12-12 reported to MD immediately after. Checked site given no visible effect. Followed up/status calls in evening & following day. No adverse effects noted. Dr spoke to parents advised to look for reaction.
Tingling of tongue 10min after shot went away in minutes, copper taste in mouth 15min after shot and still have it 4weeks later, dripping wet face and hair 1hr after shot and still have that mildly 4weeks, had chest pain and high blood pressure 6hr after shot and still have some after 4 weeks, had stomach cramps and diarrhea 1 day after shot and still have some of it 4 weeks later, got terrible vertigo and balance problems 12 days after shot and still have problem 4 weeks later, felt like fainting on and off for a week after shot, a funny woozy feeling for 4 weeks still, terrible shoulder and neck pain on right side for a week after shot, nausea on and off for 4 weeks, tired for 4weeks since shot.
diagnosed with Shingles.  March 4th, thought I had a pulled muscle, over the next few days, decided it was nerve pain and started looking into massage therapy for sciatica. A few days later hive developed and considered if it could be shingles. The next day I consulted a doctor and shingles was confirmed.
Leg pain (2-3 days - caused patient to scream). Fever (103 F - not responsive to ibuprofen or acetaminophen). Convulsions (severe for 2 hours on the evening of 12/4; sporadic for 8 hours). Swollen, red and extremely warm shot site (leg doubled in size; patient could not walk for 2 days).
day of vax pt leg became red, swollen, warm (hot), felt lumpy, followed by hives surrounding inject site. body warm to touch but no temp.
Resident sustained erythema to lateral & posterior areas of left upper arm, adjacent to injection site. Also c/o pain & slight swelling observed by this writer.
Lymph node swelled in right armpit on Wednesday night is still swollen. On Saturday 01/09 right arm swelled at injection site and had a hive. Benadryl helped with the swelling/hive at injection site.
Painfull blemishes on lower extremities x 1wk and upper extremities x 3d. 1 cm diameter black eschar on deltoid surrounded 3-4 in. diameter erythematous patch and numerous papules on chest and back.  S/P Vaccina expected reaction.  (P) Clinical observation, follow-up 2-3 days and education.
Patient with swelling of face, throat,  Immediately after getting Johnson and Johnson COVID vaccine, improved with epinephrine.
A couple of days later, I experienced what I can best describe as a "fluttering heart." Beginning around noon two days after my first COVID vaccine was administered, I began to feel a high heart rate and heart palpitations. Later that evening and into the night, I experienced low blood pressure (i.e., 104/55) for an extended period and my oxygen levels dropped to the low 90s--this concerned me because I am a healthy athlete and play a cardio-intensive sport. These symptoms worsened while I laid down to go to sleep and continued for a couple of days. After my second vaccine, however, these symptoms did not appear with the same severity; rather, they were very mild.
immed p/vax area became red, warm & itchy;red area was size of tennis ball;pt felt hot & dizzy;pt put ice on area & soon felt OK;next day still red, size of a quarter;no back to nl;