chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 25Sep03 from a health care professional regarding an adverse event occurring, it was reported that a 46 year old female pt received a dose of Fluzone, lot number U1139AA, expiration date 30Jun04, administered in the right deltoid on 22Sep03. On the same day, the pt's arm became red and swollen. The pt was seen by a physician and it was noted that the area of redness and swelling measured 6.5 inches in diameter. The pt was treated with Benadryl and ice packs to treat the reaction and reportedly the area has decreased in size. The pt's recovery status is currently unk. From additional information received on 19Nov03 from a health care professional, it was reported that the vaccine was administered IM. No other medical information was provided at this time. No further information is anticipated, this case is considered closed.
Rash following first dose  Second dose: rash, fatigue, body aches, fever
22JUN95 1 day following vax pt devel staring spells; no loss of consciousness;pt could only be distracted for only a few seconds-would return to staring again; no fever noted;lethargic; seen by MD 23JUN95
Right after the first shot, I began experiencing very irregular heart beat rythyms both at night while trying to sleep and during the day and this lasted about a week.  I went ahead and got the 2d shot 2 weeks later and the same thing began that night also.   The irrgular heartbeat and fluttering  feeling lasted about another week.  I went to my regular doctor clinic and saw Dr.  He referred me to Cardiology Clinic where I saw Dr.  The appointment was weeks later.  I went through several tests that Dr ordered.  They found no issues as the issues had subsided by that time.  I still feel that kind of queasy since the shot and am wondering if I screwed up getting it.
7/11/08 - Client's mom phoned & stated that child had sm. red area on Lt arm (deltoid).  Denies pain - in arm.  Mom brought child to office.  Area on Lt arm was red & about the size of a 50 cent piece.  Mom instructed to call or go see child's MD.  Mom called MD.  He stated to give child ADVIL and to apply warm compress.  7/14/08 - Called mom - she stated area on arm was no longer red or swollen & child was fine.
Patient reported arm/shoulder pain that started 1 week after the shot and loss/change in taste sensation.
Soreness at injection site that has progressed over 2 month period to an intermitten deltoid muscle ache that at times is "severly sore".  No visual palpable abnormality.
Anaphylaxis with hives and lip swelling. Required Benadryl and epipen admin.
Had blood clots in urine 3/8 to 1/4?. Doctors thought uti but I never had or have had issues since.
Patient presented to ED on 5/12/21 with Bell's palsy.  Reported symptoms started 5/9/21. Initial symptoms was loss of taste.
Pins and needles throughout my body; I dont want to feel like this, because it hurts; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced pins and needles throughout her body, "started pinky and ring finger", "getting worse". Caller asked if the 2nd dose will make this happen again, or make the symptoms worse.  Caller said, "I dont want to feel like this, because it hurts". The outcome of the events was unknown. Information about batch/lot number has been requested.
Racing pulse (150 bpm); Fever (99.7 F); Body aches; Pain at site of surgery within past years; Dry mouth; Loss of taste; Loss of smell; Soreness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167), via an unspecified route of administration in the left arm on 14May2021 at 10:15 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included major depression, tenosynovial giant cell tumor and soft tissue inflammation of the back and neck. The patient had known allergies to penicillin, zolpidem tartrate (AMBIEN), walnuts and pecans. Concomitant medications included sertraline hydrochloride (ZOLOFT), cyclobenzaprine hydrochloride (FLEXERIL), ibuprofen (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729), via an unspecified route of administration in the left arm on 20Apr2021 at 12:00, as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 00:00, the patient experienced racing pulse (150 bpm), fever (99.7 F), body aches, pain at site of surgery within past years, dry mouth, loss of taste, loss of smell and soreness at injection site. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 15May2021 at 00:00, the patient underwent lab test and procedures which included body temperature and the result was 99.7 F and for pulse rate the result was 150 bpm. The clinical outcome of the events racing pulse (150 bpm), fever (99.7 F), body aches, pain at site of surgery within past years, dry mouth, loss of taste, loss of smell and soreness at injection site were resolving at the time of reporting.    No follow-up attempts are possible. No further information is expected.
fever for about 2 hours; swollen upper arm around the injection for about 4 days
Difficulty breathing; A  spontaneous  report (united states) was received from a consumer concerning a female patient of an 79 year old who received  Moderna's COVID -19 vaccine (mRNA-1273) and experience the occurrence of DYSPNOEA (Difficulty breathing ).     The patient's past medical history was not provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SIMVASTATIN, AMLODIPINE, DICLOFENAC and OMEPRAZOLE for an unknown indication.    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) ( batch number -026L20A0)(unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, DYSPNOEA (Difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  in response to the event was not reported. The outcome of event was difficulty breathing was not reported.
Patient was sitting in her chair about 10 minutes after her vaccine was given to her and she was complaining to her mom that she could not see. I checked to make sure she was not having an allergic reaction did not have ay throat swelling or facial swelling. Her eyes were dilated and her skin was pale and clammy. Mom wanted us to call rescue so we did and her blood pressure was low. She did not get transported.
client requested the vaccine in his gluteus and was already upset about being forced to get it at all- wife was very concerned . discussed the fact this was not approved site and the risks of pain and unknown absorption at that site was discussed but he insisted. and I assessed the risk vs benefits as well and gave him the  vaccine in the right gluteus like he requested. Observed for 15-20min no reaction education given verbally was competent cognitively to understand and was able to read literature use computer assessed.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On 27th October 2020, 89 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient had an episode of Shingles after receiving 1st dose of Shingrix.  Consented to follow up.
Pt came to the ER via ambulance with SOB, difficulty breathing, confusion and combativeness which had gotten worse over the day 4/3/21. He had a rash all over his body..  After the respiratory  treatments failed, pt was intubated and transferred to a higher level of care and expired on 4/4/21
After given the second COVID vaccine, patient was sitting out in the lobby and in about 10 minutes, the patient stated he started feeling nauseous, dizzy, lightheaded, and his left arm, left leg, and his head started feeling tingly. Took patient back at 1325 to get a set of vitals; BP was 134/83, HR was 95, and O2 was 99%. Patient stated after I was done with vitals, his symptoms resolved. Patient was given water and offered PB crackers. Patient went back to the lobby until 13:40 and before he left, I took another set of vitals. BP was 132/74, respirations were 20, temp was 97.9, HR 98, and O2 was 97%.
20 lb weight loss; she cannott walk, becoming bed bound; gastrointestinal issues; not eating; worsened dementia; Guillain-Barre Syndrome; Initial information received on 04-Mar-2021 regarding an unsolicited valid serious case from pharmacist on behalf of a consumer.  This case involves a 100 year elderly female patient who had worsened dementia (dementia), Guillain Barre syndrome (Guillain-Barre syndrome), 20 lb. (pound) weight loss (weight decreased), was unable to walk, had become bed bound (gait inability), had gastrointestinal issues (gastrointestinal disorder) and was not able to eat (feeding disorder), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included SODIUM (NA).  On an unknown date in January 2021, the patient received 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number: UJ500AB and expiry date: 30-Jun-2021] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date in January, 2021, the patient developed possible Guillain-Barre Syndrome (Guillain-Barre syndrome) (as reported it began the day after getting the vaccine in Jan, 2021), worsening of dementia (dementia), (serious events) and had gastrointestinal issues (gastrointestinal disorder) resulting in not eating (feeding disorder), had 20 lb. weight loss (weight decreased), unable to walk, became bed bound (gait inability) (non-serious), (exact latency unknown), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Guillain-Barre syndrome and dementia were assessed as medically significant.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient did not recover from the reported events.; Sender's Comments: This case concerns a 100 years elderly female patient who presented with worsened dementia, Guillain-Barre syndrome, gastrointestinal disorder, weight decrease, gait inability and feeding disorder after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible. Concomitant medication included Sodium for unknown indication. There is, moreover, no information regarding patient's condition at time of vaccination, past history and laboratory test. Based upon the reported information and advanced age of the patient, the role of the  suspect vaccine cannot be assessed.
Abdominal rash with red patches covering 90% of abdomen appeared 48 hours after injection with no itching , applied topical otc hydrocortisone cream one time, skin clear at seven days.
She received the vaccine, and went to bed at midnight and felt great all day long.  She believes about 5 minutes later started having chills.  She has a weighted blanket and had that with 2 other blankets on her, and started shaking, and then her teeth started chattering and could not prevent them from banging together.  She was afraid she was going to break a tooth.  This lasted for almost an hour.  She finally fell asleep and normally does not move when sleeping, and tossed and turned all night.  She usually gets up a couple of times a night to use the bathroom, and did  not get up until 6:00 Am, and when she tried to get up she was woozy, and was not able to walk due to feeling like she was going to fall over and almost fell in the bathroom but has grab bars that she was able to grab.  She normally gets up at 4:00 Am, and got up at 8 after getting up at 6.  She was not able to sit up and when she got up for the day was listing like a drunken sailor and not able to eat and managed to get some water down.  She did take a Tylenol, and took her VS which were normal.  She had tried to call her doctor but due to weakness was not able to.  She was still uneasy from a deep sleep last night, but today she is feeling better but afraid of losing her balance.  Her arm is still a little sore, but pretty good right now.
Complained of chest pain at 3:50 pm may 15th. He went and layed down across his bed was coherent and talking, suddenly passed out. 911 was called and chest compressions were started.  Ambulance arrived his condition was 60/40 bp and heart rate of 40. Taken to hospital where he never recovered and passed away.
Redness below injection site of L deltoid extending to elbow. Rash R arm red and bumpy. Bump tip of tongue.
two days after the shot the injection area looked pink, was tender to touch but I  thought it would go away. I got the shot on April 10th, the injection site has become more tender, swelled some ,has a 'granular feel under the skin, pink in color . At first the area just felt itchy but now has become a larger pink area and my arm feels sore/tender from shoulder to elbow; the discomfort is getting worse with each passing day. I see on an information center site something called Arm Rash or CoVID  Rash, mine doesn't look like a rash, no spots, no blisters, just swollen  pink tissue radiating  from the injection site that is not improving with the passage of time.
Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours; After receiving 1st dose, he had slight soreness in the injected arm; After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours), MYALGIA (After receiving 1st dose, he had slight soreness in the injected arm) and PYREXIA (After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included BPH. Concomitant products included SALBUTAMOL SULFATE (INHALERIN) for Asthma.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced DYSURIA (Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours), MYALGIA (After receiving 1st dose, he had slight soreness in the injected arm) and PYREXIA (After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DYSURIA (Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours), MYALGIA (After receiving 1st dose, he had slight soreness in the injected arm) and PYREXIA (After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours) outcome was unknown.               Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Live follow up received on 13-May-2021: Non-significant follow up appended; Sender's Comments:
Hospital 8/29/21.  Received 2nd Pfizer COVID shot 7/31/21
Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Joint pain, at a dose of UNK dosage form, qd. On 21-Mar-2021, ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported
patient passed out for few seconds but woke up immediately. patient was given orange juice and ems arrived. pt left store on feet and didn't receive any treatment from ems. blood pressure and oxygen level were all normal
On November 11, 2021 I was having surgery and had a more severe reaction to anesthesia that was more severe than normal.  I vomited a lot.  The antibiotic given after surgery was Keflex.  The symptoms began as itching on my hands and feet.  I felt flushed and my skin turned purple.  My heart rate was elevated.  I used a walker to go to the hall to get help from a nurse and woke up to CPR.  I had gone into cardiac arrest.  They noted that I was allergic to Keflex.
few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionally her heart is still quivering for no rhyme or reason; Vomiting; exhausted all day from being sick; exhausted all day from being sick; feeling slightly queasy/queasiness; diarrhea actually started before 1 AM/but was mild and escalated and by 1 AM it was extremely bad; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL9264; Expiration Date: May2021), intramuscular, administered in Arm Left (left upper arm) on 25Feb2021 11:00 (at 70-year-old) at 0.3 mL, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications.  Vaccination Facility Type was clinic. The patient previously took flu shot (she took the flu shot every fall and she has never had a reaction like this). It was reported that the patient started feeling queasy within 1 hour of the dose the same day. She confirmed by 1 AM 26Feb2021 she had diarrhea and vomiting which was about 14 hours after shot. She says the diarrhea actually started before 1 AM, so could have been 25Feb2021, but was mild and escalated and by 1 AM it was extremely bad. She confirmed the diarrhea was mild the same day as the vaccine and then got worse. She has also had a few heart quivers since this happened nothing constant but occasionally she feels like her heart is trembling. She thinks it was Saturday which would have 27Feb2021 because Friday, the day after the vaccine she was exhausted all day from being sick and maybe from the vaccine also but she thinks it was the next day, Saturday when she started occasionally feeling her heart  jumping around a bit. She says occasionally her heart is still quivering for no rhyme or reason, just every once in a while she notices it. She says hopefully if she does take the second shot she will do better. The outcome of the event " few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionally her heart is still quivering for no rhyme or reason" was not recovered, "exhausted all day from being sick" was unknown, while for other events was recovered.
pt presents to hosp with cough, SOB and diarrhea; positive for COVID; given Decadron; O2 supplementation; transferred to ICU; intubated; vasopressors; COVID pneumonia; pt's condition worsened and he passed away in the hospital
I had a fever and really bad headaches for three weeks after the shot on and off. It did get better around 05/2021. I had this very strange pain in my back, almost like my spinal cord. I have herniated discs and the shot intensified the condition and I was barely able to walk to the bathroom. I also very fatigued. I contracted COVID-19 around Christmas. It started with my throat then I developed a fever of 102. It affected my voice box. I could barely function. I also had diarrhea and my fever kept spiking. I got a rash all over my back and torso area, they were almost like blisters. I took Benadryl and Advil. The Benadryl eased the hives. My doctors told me that the COVID-19 is gone now but I developed pneumonia and my platelets in my blood are very high. I also had a right bundle blockage. Until this day I still get the rash on and off. They put me on erythromycin. My oxygen level went down to 89/90. I was on four cycles of steroids and antibiotics. I was also on prednisone. As of today, I still have a low grade fever on and off and shortness of breath. I now have Cushing disease from the steroids. I have an inhaler to help with my breathing. My cardiologist has me taking ibuprofen. I have an appointment to get a CAT scan to see if there is damage to my heart.
Experienced minor muscle aches one day after second Covid-19 injection injection; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Experienced minor muscle aches one day after second Covid-19 injection injection) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Experienced minor muscle aches one day after second Covid-19 injection injection). At the time of the report, MYALGIA (Experienced minor muscle aches one day after second Covid-19 injection injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Action taken with mRNA( COVID-19 Vaccine) was not applicable No concomitant medications were reported Treatment includes two ibuprofen pills to treat his minor muscle pain