chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm swelled, turned red and extremely painful.  Pain extended to shoulder, up my neck, under my arm etc.  Very painful to touch. Hot to touch. Pain began to subside 6/26/2014 about 2:00 PM. As of 6/27/2014, most of pain is gone.  Still some swelling and redness.
Swelling with redness at site of injection. Pain at site, restricted range of motion. Hives developed 24 hrs after injection with increased redness. Warm to touch. Left arm slightly swollen after receiving Tdap vaccine. Did not treat with anything. Returned to clinic on Thursday.
Two weeks after the vaccination, I saw a bump on my hand.  When i am looking at the back of my hand, my thumb, you could see my vein, my vein was a dark, greenish purple and usually I can't see my veins, I saw a little bump on my vein, the size of a lentil pea. The doctor asked if I had bumped it, but  I had not bumped my hand. It  began getting bigger, it went from the size of a lentil bean to the size of a quarter and changed color, it looked like it had clear or white fluid in it.  The doctor said it was a firm mass and removed it to see if it wasn't cancer. The doctor said it was non-cancerous.
pt recvd vax;"blisters" at site of inject where she gets cuts or bruises;inadvertently recvd a 2nd flu shot;
13MAY98 pt seen by MD w/OM;16MAY98 mom reported pt not walking & acting drunk;pt seen by MD w/questionable balance, would not stand voluntarily;21MAY98 pt refusing to stand,having trouble sitting w/balance;dx acute cerebellar Ataxia
Tinnitus/ringing in ears; Fever; Nausea; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ENU202 and expiration date not reported), via intramuscular, administered in Arm Left, on 02Mar2021 15:00 (at the age of 72-year-old), as dose 2, single, for COVID-19 immunisation in clinic at a football stadium. Patient had no medical history of compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: None. The patient was allergic to sulfa drugs. There were no concomitant medications. The patient previously took statins and lipitor [atorvastatin] and experienced allergy years ago. Patient had no family history. Historical vaccines included shingles vaccine (manufacturer, lot or expiration unknown) about a year ago and was very sick for 36 hours, fever, nausea and did not get second dose; Flu vaccine on Sep2020; and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9269 and expiration date not reported), via intramuscular, administered in Arm Left, on 09Feb2021 (at the age of 72-year-old), as dose 1, single, for COVID-19 immunisation in clinic at a football stadium. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. The patient experienced fever and nausea on 03Mar2021 11:00. On 20Mar2021 evening, the patient experienced tinnitus. He got a hissing noise, ringing in ears and thought it was something in the kitchen. It has been constant. He was able to sleep, but it was annoying. Patient had no relevant test. The outcome of fever and nausea was recovering while the outcome of tinnitus was not recovered.  No follow-up attempts are possible. No further information is expected.
Fever,nausea and vomiting since 10/19/10 one day after flu vaccine also c/o headache.Patient admitted with acute aseptic meninigitis and was treated with Rocephin 2 grams IVPB every 12 hours and was discharged to home with Acyclovir 800 mg TID p.o for 10 days.
Fatigue; Headache; Oral ulcers; Muscle aches; This is a spontaneous report from a contactable nurse (patient). A 52-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Lot number: EL0142PF; Expiration date: unknown), via unspecified route in arm left on 06Jan2021 at 10:45 (patient was 52-year-old at the time of vaccination) as a 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history include history: hypothyroid, htn, depression, arthritis, Allergies to medications, food, or other products: TRAMADOL, AMITEZA. The patient received medications within 2 weeks of vaccination. The most recent COVID-19 vaccine was administered in hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, has the patient been tested for COVID-19 was unknown. On 07Jan2021, at 7:00, the patient experienced Fatigue, Headache, Oral Ulcers, Muscle Aches. The events are not serious. The patient had not received any treatment for events. The patient received second dose of BNT162B2 on 27Jan2021(Lot number: EL3249) on right arm. The events were recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.
Patient received initial COVID vaccine Moderna on 8/31/21. Patient inadvertently given Pfizer vaccine 0.3ml dose as 2nd dose instead of Moderna.
LOCAL REACTION AT INJECTION SITE WITH ERYTHEMA, INDURATION, WARMTH AND MILD VESICULAR REACTION.  MILD SYSTEMIC REACTION WITH MYALGIA.
She received her vaccines 1 week ago, 7/22. Has been seen now 3 times for sx's fatigue, fever,  nausea, headaches, swollen glands, body aches and pain at the injection sites. F/u test, strep screen performed on 7/24 were negative. Labs were drawn and CBC, CMP were essentially normal and mono screen negative. Mom is concerned, convinced that all of her daughter's sx's were caused by the vaccines, despite our discussing the possibility of her having a possible viral infection. Also, pt and family had just returned from 4 weeks abroad, returning late on 7/20 and pt. was jet-lagged. Pt, was feeling better over the past few days, then nausea, headache and fatigue began again last night and this morning. Mom brings pt in for another evaluation and discussion of the vaccines. Would like this to be reported as a Vaccine Adverse Reaction. Also, is concerned because pt is scheduled to go to camp this weekend leaving on Sunday, 8/2.
Left arm red and swollen. Left arm warm to touch. Arm swollen approximately 4-5 inches in deltoid area. Child in no apparent distress. Child moving arm freely. Child to follow up with nurse practicianer Tuesday am.
Member states did not receive a papule at injection site but on 08/27/2011 rash almost acne break out on arms and back. States she was on leave so she did not come in to clinic until today, 09/19/2011. Member was evaluated by Dr and released with profile restrictions.
Aches, headache, low grade fever.  Started a few hours after vaccination and continued into the next day.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 18-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions by a pharmacist. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
This was the second dose.  In the first dose I had mild throat and tongue swelling (airways remained fully viable) and an itchy throat.  For the second, I prophylactically treated with six allergy and asthma medicines I already use in various ways after consulting with two friends who are doctors.  My reaction was either the same or slightly better on the throat swelling front with this second dose, but a bit worse on the throat itchiness front.  The throat swelling mostly went away after an hour and the throat itchiness lasted about two hours.
Headache, chills, fever, fatigue, nausea, dizziness, myalgia, joint pain. Fever lasted 4 days, then keeps coming back (99.5) Every other day headache,  fatigue and chills come back  and are still occurring as of today (day 8).   I am part of an clinical research study for people with immune deficiency, tracking whether they will produce antibodies to the COVID vaccine. Regular blood draws for a year will determine this.  Dr.
pt stated that her left arm started hurting very badly around the injection site but the pain moved down the entire arm by the next day.  those symptoms subsided then on 2/16 she developed a itchy, red rash on entire body even the bottom of her feet.
TOOK THREE UNREFRIGERATED DOSES; DID NOT TAKE DOSES ON SCHEDULE; This spontaneous case report (PVX2019-2653) was received from a pharmacist on 24-Oct-2019. It described a female consumer who "took three unrefrigerated doses" (PT: Product storage error), and "did not take doses on schedule" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took one dose of refrigerated Vivotif and then left Vivotif unrefrigerated for seven days before completing the rest of the doses.  Action taken with Vivotif with respect to reported event was not applicable.   The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the event "took three unrefrigerated doses", and "did not take doses on schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three unrefrigerated doses", and "did not take doses on schedule" was considered as not applicable.
Red skin scar; This spontaneous case was reported by a physician and describes the occurrence of SCAR (Red skin scar) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M2OA) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (similar reaction to event.). Concurrent medical conditions included Shellfish allergy, Drug allergy (PEG solution), Bigeminy (Heart PVC's), Hypertension and Type II diabetes mellitus. Concomitant products included ATENOLOL, HCTZ, METFORMIN, IBUPROFEN (ADVIL [IBUPROFEN]) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced SCAR (Red skin scar). On 06-Mar-2021, SCAR (Red skin scar) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No treatment medication was reported. Since the patient was hyper-sensitive to PEG Solution which causes violent vomiting in patient, the reporter wants to know whether the PEG solution used in the vaccine could be a root cause of the issue.   This case was linked to MOD-2021-020684 (Patient Link).
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 44 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no illness at time of vaccination. Patient had no past history of similar event. Patient had no adverse event after any previous vaccination(s). Patient had no history of allergy to vaccine, drug, or food. Patient had no pre-existing acute illness 30 days prior to vaccination. Patient had no history of hospitalization in last 30 days, with cause. Patient had no family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-DEC-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220260967, 20220261011, 20220261063, 20220261042, 20220261024 and 20220261092.
Narrative: Patient received J&J COVID-19 vaccine on 4/10/21. Contacted nursing triage line 4/16/21 with face and eye swelling that started when he woke up that day. He was directed to ED for evaluation. In ED indicated he developed an itchy rash on both arms two days after received J&J vaccine. He did not think much of it as he had been working in his flower bed. On 4/16, woke up with periorbital swelling and itchy patches on face and behind left ear. Otherwise feeling well. No fever, chills, body aches, nausea, vomiting, tongue or lip swelling, difficulty breathing or difficulty swallowing. Takes hydroxyzine BID for anxiety. Has been taking it and still experiencing urticaria. Has some itchy areas on abdomen but no rash on abdomen, trunk or legs. Final diagnosis = urticaria, could be related to vaccine versus outdoor activity/plant exposure. Received treatments to resolve symptoms as outlined in report.
No adverse events. Patient received #1 Moderna on 2/5/21 and #2 Moderna on 3/85/21 so he was supposed to not qualify for Pfizer booster.
At the opening of the mobile clinic event, Pt arrived with required vaccines for school.  Writer acquired Varicella and MMR from freezer, checked vials, administered vaccines, and released patient.  Later in day, writer realized that MMR was taken from Freezer and was therefore probably not an MMR.  Verified with return to clinic to enter vaccines, confirmed mistake, informed supervisors and concerned parties.
By night, started to have pain on both legs--started from ankles going up like streams.  Patient rarely gets headaches, got headache, stomachaches, and labored breathing.   Patient could not sleep.  Got up the next day, felt awful but went about her day.  Patient went to bed and woke up feeling betterlike if had recovered completely. Patient went to yoga,   drank water and got a headache.  Patient has had an intermittent headache since then.   Patient called the doctor and waiting to hear back. Patient reports no problems after the first dose of vaccine.   Patient took no meds or did any treatment to feel better.  Arm hurt but heard everyone's does; now has slight pain on arm.   Patient notes that she only gets headache with flu.  Patient not at a 100% because of headache but functioning well otherwise.
Passed out; Strain on heart; Confusion; Lethargic; Not feeling well; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug hypersensitivity, Hypertension and Anxiety. Concomitant products included AMLODIPINE BESILATE (NORVASC), CLONIDINE HYDROCHLORIDE (CLONIDIN), BUPROPION HYDROCHLORIDE (WELLBUTRIN), LEVOTHYROXINE and CEFIXIME (FLEXERIL [CEFIXIME]).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), CARDIAC DISCOMFORT (Strain on heart), CONFUSIONAL STATE (Confusion), LETHARGY (Lethargic) and MALAISE (Not feeling well). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), CARDIAC DISCOMFORT (Strain on heart), CONFUSIONAL STATE (Confusion), LETHARGY (Lethargic) and MALAISE (Not feeling well) 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.   The patient followed up with doctor on 03/26/2021.  No treatment medication was provided by the reporter.  Patient reports after she left the site and drove about thirty minutes away, she had to pull into parking lot because she felt bad and confused. States she has passed out x2 that same day. Reported feeling lethargic and a strain on her heart.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of drug hypersensitivity, and anxiety remain as confounders.
The first symptom I had was a sudden stomach pain with loose stool and diarrhea. I got very cold all of the sudden. This diarrhea persisted for almost 10 days. I felt a tingle and tightening in my throat and started to develop a cough, it was an itchy cough. As the day went on I had a fever, and I normally don't get fevers and noticed this right away. On July 23rd the cough began to worsen and at that point it got worse and worse and I could feel my chest getting tighter. I could not sleep because of the diarrhea and the cough for a whole day. The temperature being off was the worst even though my fever did drop fast. My oxygen levels remained stabled and normal however. The next day I called my doctor in fear I was getting worse and I did not want to take the risk that something will happen suddenly. Doctor gave me PAXLOVID and I felt relief within 4 to 5 hours. I also took MUCINEX DM. The cough became better right away and was still really tired. On day 5 or 6, after PAXLOVID I retested and I was still positive for COVID but was negative by the 10th day I was negative. I went back to work. I still have a persisted cough and yesterday my sudden diarrhea has come back. Not sure if its just random. I am going to test again now knowing that people rebound all the time after PAXLOVID.
patient self reported tetracycline allergy that resulted in difficulty breathing and hives.  Reaction happened many years ago. I asked patient to wait an additional 10 minutes for a total of 25 minutes so we could keep him under observation.  After his 25 minutes patient reported that his fingers felt swollen and he had taken his wedding ring off to show me.  Patient also reported that his lips felt "tingly".  I observed the patient and noted no flushing, no sweating, no rapid pulse.  I took the patients blood pressure and it was 121/80.  I gave the patient Benadryl  and asked him to wait for another 15 minutes so I could observe him.  After the 15 minutes I observed the patient again and he still had no flushing or swelling and he reported that he no longer felt "tingly" and felt fine.
Pt indicated on consent form that she was requesting a flu shot, prior to administration RPH confirm that a flu shot was going to be administered and pt confirmed. After vaccine was administered pt stated she was requesting another vaccine and had received a flu shot this season.
Fevers after midnight and intense body ache for around 24 hours, Tylenol it didn?t help me at the end of the day I tried with iboprofen, that one worked better. The fever gone and the intense body ache too.  I am still with outcome headaches like migraine at the right side of my face, rigid neck and pain . Stomach upset after iboprofen
1 hour after receiving vaccines, patient developed a low grade fever that progressively increased to 105F in the middle of the night. She then had a shaking and unresponsive episode that was consistent with a febrile seizure. No other symptoms.  Presented to hospital that evening.
Pt experienced flu-like symptoms : , fever, chills, terrible headache, symptom severity of 5-6
The patient had a very severe side effect profile from the second dose of vaccine:  "worst I've ever felt" with myalgia, headache, fever and fatigue.  This subsided and then on day 3 he developed severe substernal chest pain and came to ER where his hs-cTnI was > 2000 ng/L and peaked at 6700 ng/L.  His ECG, echo and cardiac cath were normal but MRI showed evidence of myocarditis with mild left ventricular dysfunction. He is doing well clinically and we are managing expectantly.   This appears to be immune mediated myocarditis from the Moderna vaccine
This spontaneous report as received from a physician refers to a 63 year old female patient with no drug allergies. The patient's pertinent medical history included cholesterol, high blood pressure, osteoporosis and seasonal allergies. Approximately on 15-MAY-2014 (reported as about a week ago) the patient was vaccinated with ZOSTAVAX. Concomitant medications included unspecified cholesterol lowering medications, unspecified antihistamines, unspecified hypertension medications and unspecified osteoporosis medications. Approximately on 16-MAY-2014 (a day or so) the patient experienced unspecified herpes blisters on an unspecified location. Lab studies performed were none. The patient sought medical attention, the patient informed the physician's office on 22-MAY-2014. The outcome of unspecified herpes blister was reported as not recovered. The causality was not reported. Additional information has been requested.
woke up 9 days post injection to a sore arm, when I looked at the arm in the mirror there were 4 red marks, 1 the size of a quarter maybe a little larger and three more the size of finger prints.  The red marks were slightly warm to the touch.  Arm was a little sore, but not bad.  As the morning progressed the red marks got larger and my arm began swelling.  The temperature of the red area became warmer.  Slight discomfort, more discomfort when bending over and hanging arm.  I took aceteminophen and iced the arm.  When I removed the ice pack the area was still very warm to the touch.  As the day progressed and went into the Monday the red mark got bigger and my arm was more swollen.  I contact my primary care and he expressed concerns of cellulitis based on the progression and symptoms.  I had a cbc and he placed my on antibiotics.  My cbc came back completely normal.  I am continuing the antibiotics as precaution.  The evening of Monday, January 18 the arm was starting to signs of the inflammation reducing. Tuesday, January 19th the red mark is smaller and the arm is not as swollen ( I have only taken two doses of antibiotics as of this morning).