chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Big bump in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Big bump in the injection site) in a male 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) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE SWELLING (Big bump in the injection site). In February 2021, VACCINATION SITE SWELLING (Big bump in the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment was provided.   This case was linked to MOD-2021-076391 (Patient Link).
Extreme pain at shingles shot site (right upper arm) like hot ice pick jabbed into upper arm. Muscle and joint pain followed for next five weeks--stiffness on joints upon sitting for longer than 10 minutes, noticeable lack of flexibility in ankles and feet when walking; pain and stiffness began abruptly and after five weeks, is beginning to taper off; still stiff joints and sore muscles at present date (11/23/2019), but gradually lessening each day.
celiac disease; genital things, little lesions maybe, on my privates; I may have had it [Human Papilloma Virus].; This spontaneous report refers to a 83-year old-female patient reporting on herself. Her concurrent conditions and medical history was not reported. She had no allergies. Concomitant medication included "a lot of vitamin".   On an unknown date (reported as a long time ago), the patient was vaccinated with a single dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection, 0.5 milliliter, route of administration was reported as injection, (anatomical location, lot # and expiration date were not reported) for prevention of Human Papilloma Virus (HPV).  On an unknown date (reported as a long time ago, but might have been when the patient was a senior), the patient experienced genital things, little lesions maybe, on her privates. She thought she might have had HPV. It was unclear what age the patient received quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL), and whether it was received prior or subsequent to the development of genital lesions. She sought seeing a skin doctor and being given an antibiotic- doxycycline (reported as "DOXYCYCLINEN or something like that") which made the genital lesions went away without relapse or recurrence. She also had celiac disease (date of diagnosis was unknown, celiac disease was also reported as the patient's pertinent medical history). The patient accepted offer to send the prescribing information. No additional adverse events or product quality complaints were reported. No further information was provided. The outcome of genital lesion was reported as recovered, the outcome of on an unknown date human papilloma virus infection and celiac disease was unknown.   The causal relationship between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported.  Upon internal review, celiac disease was determined to be medically significant (MS).
can no longer smell or taste anything; can no longer smell or taste anything!; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (can no longer smell or taste anything) and AGEUSIA (can no longer smell or taste anything!) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (can no longer smell or taste anything) and AGEUSIA (can no longer smell or taste anything!). At the time of the report, ANOSMIA (can no longer smell or taste anything) and AGEUSIA (can no longer smell or taste anything!) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug details were provided. No treatment details were provided.   Reporter did not allow further contact
This spontaneous report was received from a medical assistant regarding an unspecified amount of patients of unknown age and gender. The patients' medical history or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II (lot number: M045393, expiration date: 14-NOV-2018; and lot number reported as "N049212", expiration date: 16-DEC-2018) for prophylaxis. M-M-R II was reconstituted with sterile diluent (manufacturer unknown). According to the reporter, the doses were exposed to a temperature between 47 degrees Fahrenheit (F) to 77 F for 72 hours. No adverse effects were reported. A digital data logger was involved. Lot number N049212 is an invalid lot number for M-M-R II.
Circle rash appeared today. Itchy and warm. About 3 inches in diameter around injection site.
COVID-19; COVID-19; Bad respiratory infection; This is a solicited report received from marketing program, database, based on the information received by Pfizer. (manufacturer control number 21K-163-3943566-00). A 71-year-old contactable female consumer (patient) reported for herself that she received bnt162b2 (BNT162B2), intramuscular on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing at citrate free 40 mg (40 mg,1 in 2 week) for moderate to severe chronic plaque psoriasis. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced covid-19 and bad respiratory infection. It was further reported that this is a solicited report from the consumer of an elderly female with events of non-serious bad respiratory infection and COVID-19 with HUMIRA (ADALIMUMAB). PFIZER BIONTECH COVID-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. She received COVID-19 Vaccine manufactured by Pfizer. The patient underwent lab tests and procedures which included Covid-19 test showed covid-19 on an unspecified date. The action taken in response to the events for adalimumab was dose not changed. The outcome of the events was unknown. The reporter's causality for the event(s) of bad respiratory infection and COVID-19 with HUMIRA (ADALIMUMAB) was no reasonable possibility. The company causality with regards to the drug Humira and the event respiratory infection was not related while for the event Covid-19 was no reasonable possibility. In regard to the causality for the drug PFIZER BIONTECH COVID-19 vaccine (tozinameran) and the reported events respiratory infection and COVID-19 were not reported.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Covid-19, Drug ineffective, Respiratory  tract Infection) and the administration of the vaccine cannot be 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.
Left arm pain positive swelling positive warmth vaccine 2 days ago negative fever.  Cellulitis vax site.  CEPHALEXIL 250 mg TID X 10 days.
Patient developed redness with a hard lump underneath the injection site.  This later developed into cellulitis.
not to be able to smell; not to be able to taste; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (not to be able to smell) and AGEUSIA (not to be able to taste) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (not to be able to smell) and AGEUSIA (not to be able to taste). At the time of the report, ANOSMIA (not to be able to smell) and AGEUSIA (not to be able to taste) outcome was unknown.            No concomitant medication were reported. No treatment medication were given.
Pt recvd flu vax 16DEC93 & presented to ER w/severe h/a, nausea & vomiting; treated w/Fiorinal, the sx are resolving;
Severe thigh aches, weakness in legs so severe could hardly stand upright. Bad headache, lightheaded, almost passed out. Extreme nausea and stomach cramps. Overall bad feeling.
Right sided facial nerve palsy - unable to move right side of face starting day 3 post-vaccination. No fever. 9/13-15 swelling right side face. 9/15 Palsy began. T. 97.6 degrees F. 9/17 Office visit - Acyclovir and prednisolone x 5 days started.
Fever, chills, stomach pain, nausea, vomiting, tiredness, muscle aches/pain, migraine. Lasted about two days
Late evening on 3-7-14 pt experienced racing heart, chest tightness/SOB, hives, vomiting and low grade fever and generalized body/joint aches. Pt seen in ER at hospital on 3/8/14 - given injections of BENADRYL and anti nausea med. Immediate relief of N/V. Sx completely resolved by 3/9/14.
My tinnitus, which is usually relatively quiet and manageable, got much louder!  There is no treatment that I am aware of.   I haven?t gone to a doctor yet, as I was hoping that it would go back down to a normal level on its own.   It has not  gone back down yet, as of day 9 (following the first shot of the Pfizer Covid vaccination)
Really bad pain on right leg; Burning sensation; Had drop foot, and driving for him was very tough; the muscle that raises your foot up and down wouldn't work at all for him; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 68-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 14Mar2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 21Feb2021 as dose 1, single for COVID-19 immunization. Patient had the first dose of the Pfizer BioNTech COVID-19 vaccine last 21Feb2021 and the second dose last 14Mar2021. He had a really bad pain on right leg with burning sensation and drop foot on same leg. He had drop foot, and driving for him was very tough, the muscle that raised your foot up and down would not work at all for him. He could not move his foot at all, up or down, and it was like his ankle was swollen, and felt almost like wood. He mentioned the nerve damage was so long, he thought is this ever going to get better. Then 3 weeks ago, in about a month, he could start moving his foot up and down and his range had got a little better though it was still tough to move, and he still kind of has a drop foot. He was given Gabapentin. He mentioned he still had 20 percent of needing to get back to how he was before the shot. He said it had gotten better, pain was gone. He mentioned that the burning was like bubbling, boiling, burning, and he could feel his skin doing the same thing, like lava, when he put his hand on it, there was no heat or burning sensation on it, where he felt like it was doing that. He mentioned that it mostly seemed like a lot of nerve issues. He mentioned when he walked in tennis shoes, he could almost walk normal. It was still going to be awhile.This had not happened to him until 2 days after the second shot. Doctor told him it was not related to the vaccine but he was concerned that his experiences were related to the vaccine and that the doctor did not know what he was talking about because a dental hygienist who was a family member sent him something about some of the symptoms he had been having. Family member found something that was similar or exactly like what he experienced and he was convinced that it was Covid related. He wanted recommendations to speed things up with regards to his recovery. On an unspecified date in 2021, the outcome of the event pain in leg was resolved that of burning sensation was unknown while of foot drop was recovering.   Information on the lot/batch number has been requested.
Swelling from the injection site down the arm ending with a know at the inside of the wrist, lasted 3 days Swollen tongue, mouth, not severe enough to be treated, did interfere with speaking.  Stayed the same for three days then gradually lessoned for another three days.
Vaccinee states he experienced severe itching at the site of the Typhoid IM injection on the evening of the date of vaccination.  After scratching it he states he noticed a small pimple-like appearance to the injection site.  Upon visual inspection today 7/17/07 there is no abnormality noted to the skin at the injection site and vaccinee states itching is resolved.  He also states the IPPD site itched.  Upon inspection there is mild redness to the site but no induration and the itching has resolved.  He states that he has received many IPPD's through his civilian employer and never experiencing this itching on any prior occasion.
Booster Dose following Jannsen vaccine. Patient said immediately after being vaccinated, she felt as if she was going through AFib. Heart was racing and she felt nauseous. Blood pressure was checked and was within normal range. Heart Rate was checked and was within normal range.  Called the patient's cardiologist and she will follow up with them today for an EKG. After 20 minutes at rest, patient felt okay to drive herself.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-MAR-2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-APR-2016, the patient was treated at physician office for blistering vesicular outbreak and decreased immune symptoms, which was diagnosed as herpes zoster, or shingles. She was prescribed PERCOCET, gabapentin, and acyclovir for management of her painful symptoms. On or about 10-MAY-2016, she sought subsequent treatment and was diagnosed with post herpetic neuralgia, a condition of chronic pain and nerve damage secondary to herpes zoster infections. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
very sick; Initial information received on 05-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves an unknown demographic patient who experienced very sick (illness) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious very sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Haven't had a flu vaccine in 35 years! I've known so many people that got the flu shot and got very sick. Oh, and how is it the countries that have mandatory C****d vaccines have the highest death rates?"  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.  There will be no information available on batch number for this case.
On 25th I got the vaccine, on the 27th my right arm was still sore, but it sore all the way down to elbow. This soreness was a different soreness from the first vaccine. On the 28th I notice that my right elbow  was pink and warm to touch, tender it felt like a lump was in there. I had a couple of doctors at look at it. They didn't think I needed antibiotics at this point, they suggested to leave it alone at this time. The next morning it was  still a lump, still sore and but the pinkness started to go away. By Friday it was still sore and the lump was still there but the the pinkness and warmth had went away. One of the doctors I worked with said it started to go into the joints that when I should be concerned. On Saturday my joint started to hurt, I kind of ignored it. It has been over a week and 2 days and it now it still hurting in my elbow joint, when I bend my arm it is still hurting a lot. I have never had elbow pain before getting the vaccine. I am going to call my doctor today.   With the first dose of the vaccine, I did have a sore arm but it lasted less then 48 hours.
Patient complained of tachycardia. Dr. examined the patient who stated he had a regular rhythm. After one minute of sitting, he felt better. After sitting for another 5 minutes the patient stated he was feeling tachycardia again. Denied any dizziness or lightheadedness. Dr called down to the ED. Patient escorted down to ED where they did an EKG and discharged him.
Pt came to hospital related to being shocked multiple times form icd. Pt asymptomatic for covid. Transferred to another hospital for further management of cardiac issues.
Flu; Sinus infection; flu-like symptoms; Malaise; Body aches; Felt bad; This case was reported by a pharmacist via call center representative and described the occurrence of influenza in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number A5X5B, expiry date 7th March 2021) for prophylaxis.   On 15th October 2018, the patient received the 1st dose of Shingrix (intramuscular). In October 2018, 6 hrs after receiving Shingrix, the patient experienced influenza, sinus infection, influenza-like symptoms, malaise, general body pain and feeling bad. The patient was treated with steroids nos (Steroids). In October 2018, the outcome of the influenza-like symptoms, malaise, general body pain and feeling bad were recovered/resolved. On an unknown date, the outcome of the influenza and sinus infection were not reported.   It was unknown if the reporter considered the influenza, sinus infection, influenza-like symptoms, malaise, general body pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: On 15th October 2018, the patient received Shingrix in right deltoid. After 6 to 7 hours, the patient had flu-like symptoms like malaise and body aches. She just felt bad. The symptoms lasted for a day and a half, for about 36 hours. The patient also had intermittent illnesses, like the flu and sinus infections and they were taking a lot time to treat due to their chronic nature during the 6 month window for the 2nd dose. The patient was on steroids off and on during the 6 months time period and due to these reasons did not get the 2nd dose. At the time of reporting, the patient was wanting to receive the 2nd dose.
5 days later patient experienced florid red blisters, rash on groin, thighs, to hips, below to knees, bilaterally, redness, very itchy rash. Used cortisone cream, took antihistamine, cleared in less than 12 hours. No S.O.B. No pain. No reaction at the injection site.
Began to have a fluttering in ear after first vaccine shot. Over the next few weeks turned into an occasional ringing in my ears. the ringing would move from ear to ear and eventually stop. I believed this was a symptom of stress at first. After the second vaccine shot on  May 19, 2021, I sat in the chair for 15 minutes waiting to be cleared to go home. The ringing began again.  It is now November 2021 and the ringing has not stopped since my second injection. I have developed fairly severe tinnitus after receiving both doses of the Pfizer vaccine.
Day 7 pain and round red spot the size of 1/2 dollar at injection site.
Rash on belly and sides lasting 14 days. Fever like chills lasting 48 hours.
ED on 9/9/21 with gradual onset SOB. Started w/ left thigh pain 2 days prior to ED visit. CTA positive for large bilateral PE with elevated RV/LV ratio, indicating right heart strain. US negative for DVT of either right or left leg. Concern for VITT. Initially treated with heparin drip, but then switched to argatroban. Later transitioned to apixaban. Discharged 9/13/21.
Carditis, vertigo, dizziness, shortness of breath, extreme fatigue, restless leg syndrome
Within 24 hrs of the vaccination, she experienced a "quarter-sized" tough area on the skin at the injection site. Within 48 hrs the area became larger and red/inflamed.
Tingling on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on her arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PARAESTHESIA (Tingling on her arm). At the time of the report, PARAESTHESIA (Tingling on her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Local reaction left deltoid (Pain, swelling, increased warmth induration, local adenopathy