chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 13Mar2021 (Lot number: EN6207) at the age of 72 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot No: EL3302, Anatomical location: Left arm), administration date: 13Feb2021, when the patient was 72 years old, for COVID-19 Immunization. The following information was reported: BREAST DISCHARGE (non-serious) with onset 2021, outcome "unknown", described as "leaky breasts on both sides"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "swollen lymph nodes in her arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Enquired that, call transferred from (withheld) with Pfizer. Stated that, the caller was a 73-year-old female who has had both doses of her Pfizer COVID 19 vaccinations. Stated that, one shot in 13Feb2021 & the 2nd in 13Mar2021. Stated that, she received the doses at two different (withheld) and she received no other vaccines within 4 weeks of the Covid vaccines. The caller stated that, one month after her 2nd dose, after she was already experiencing swollen lymph nodes in her arm, she began experiencing leaky breasts on both sides. Stated that, after she got the second one she got a swollen glands under her opposite arm and towards her breast, stated if she put her arm out she could feel the swollen gland. Stated that, it was a month after the second dose that she had leaky breasts. Stated that, this occurred 3 times and was a significant amount. Stated that, it happened 3 times, that the first time she was doing dishes and her shirt got all wet. Stated that, the next time it happened, it was the other side, stated then, the next time it happened it was both sides and she was soaked, her whole bra and everything. Stated that, she told her doctor and she sent her for every test in the book, a mammogram, a CT, a MRI, states they looked all around the breast and they found nothing. All the reports were negative. Stated that, the caller was now worried about it due to the push to get the booster dose, whereas she was not before. Stated that, she has followed up with her HCP regarding the concern and they did tests but nobody could give her a reason why other than the possible connection with the vaccine. HCP details were not provided. Expirations and dosages were unknown. Stated that, leaking didn't start for like a month, swollen gland she noticed about a week or so after second dose. Stated that, exact dates were unknown. Stated that, the caller wanted to know whether this was a reported side effect. Follow-up attempts are completed. No further information is expected.
PAIN IN ARM; HEADACHE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 09-OCT-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for non-infectious intermediate posterior and panuveitis ankylosing spondylitis. No concomitant medications were reported. On 10-OCT-2021, the patient experienced pain in arm. On 10-OCT-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm, and headache on 11-OCT-2021. This report was non-serious.
4/9/21 Loss of balance, trip and fall, impacting right shoulder & upper arm, back of head.
Thrombocytopenia; A spontaneous report  was received from a nurse concerning, an unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed medically significant event of thrombocytopenia.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On unknown date, prior to the onset of event, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On unknown date, after receiving vaccine, the patient developed thrombocytopenia. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event of thrombocytopenia, was not provided.; Reporter's Comments: Based on the very limited information provided on the use of the product and the onset of the event, a causal relationship cannot be excluded. Further information has been requested.
About three days after vaccine, I started bleeding and getting blood clots. I went to ER to make sure I wasn't miscarrying. I wasn't that day. Everything looked okay. Baby was measuring much smaller than it should be. I kept bleeding lightly for a couple of days. Tuesday I was bleeding heavily - I went to ER again. Hormone levels - were going up but not as they should be. From Tuesday - Friday, I didn't bleed. I started bleeding on Saturday again. And I'm still bleeding. I called my OB today and she is going to call me back in the morning to let me know what to do. I was last seen on Friday at ER again.   Pregnancy History - One other pregnancy - carried twins fine. Estimated date of delivery for this pregnancy - January 17, 2022.
Pt experienced a single febrile seizure 3 hours after receiving the Hepatitis B vaccine. Pt was transported via ambulance to ER. Evaluation by ER doctor proved WNL. Pt seen in office next day - eval was normal. PMHx is neg for previous vaccine reactions and febrile seizures.
PT was found in a epileptic state for 1 minute , came out of it. PT stated he is afraid of needles and faints when it happens
Approximately 12-20 after the injection he started experiencing significant pain and redness of the injection site. He then had swelling and some numbness. The numbness went away within 1 night. The swelling and redness continued. Mother made an appointment to be seen after calling the clinic to find out what to do about it. Mother drew around the redness on his arm and noticed the redness continued to expand distally to the shoulder. At the appointment, 2 days after the injection, it was noted that his arm was red, had +2 edema, was warm to touch, skin was firm and he had significant pain when touched. I prescribed him cephalexin to cover for staff infection and recommended benedryl around the clock for 2 days. Recommended IB for pain. Follow up in 2 days was scheduled.
little bit of soreness at the injection site; fatigue; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Chronic lung disease and Polyneuropathy.    On 28-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (fatigue). At the time of the report, INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (fatigue) had resolved.            Concomitant medication was not reported.  Patient had taken six doses of the Moderna COVID-19 vaccine. Tolerated all shots well and had not gotten sick. Patient had a little bit of soreness at the injection site and fatigue with all of the doses. This is similar compared to his experience with any other shots. Lasted 1.5 days before resolving with each dose.  Doses were given as follows: 24 Feb2021, lot number 006M20A 26MAR2021, lot number 026A21A 9NOV2021, lot number 004F21N 3JUN2022, lot number 05A22A 28NOV2022, lot number 016H22A Last dose unknown date or lot number.  treatment information was not reported.   This case was linked to MOD-2023-749422 (Patient Link).
Patient reports starting Friday 10/2/15 he experienced facial redness, rash, and itching on forehead, nose, and cheeks. Slightly improved today Sunday 10/4/15, wife reports they used coconut oil and Neosporin at home to soothe and treat.
collapses on the field; Initial information received on 27-Jan-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves an adult and unknown gender patient who had collapses on the field while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, lot number not reported via unknown route in unknown administration site for Immunization.  On an unknown date, the patient experienced a serious event "player collapses on the field and has to be revived" (circulatory collapse) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It is unknown if the patient experienced any additional symptoms/events  Action taken was not applicable.  It was not reported what specific method of 'revive' the patient received as corrective treatment for the event (collapses on the field).  At time of reporting, the outcome was Unknown for the event collapses on the field.; Sender's Comments: Sanofi company comment dated 07-Feb-2022: This case involves a adult and unknown gender patient who had collapses on the field while receiving vaccine INFLUENZA VACCINE. The causal role of the suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
Itching, light-headedness, dizziness, shortness of breath, redness on neck and arms lasting approximately 36 hours.  Benedryl and Ibuprofen relieved some itching.
. Patient received Janssen booster shot on 12/27/2021 and stated she had a swollen and achy arm the same day. Two weeks later patient stated she had diarrhea for four days then it went away and then occurred again one week later. She also stated she had a fever 2 days after receiving the vaccine. Throughout the course of events patient said her swollen arm continued and worsened and has difficulty maintaining full range of motion. She met with physician who advised the pharmacy to report side effects.
Information has been received from a physician concerning a 77 year old male who on 14, Mar 2007 was vaccinated with a 0.65 ml dose of zoster vaccine live (Oka/Merck). On 14, Mar 2007 the patient experienced a severe red swollen arm at the injection site. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. No additional information is available.
T78.3XXA ANGIOEDEMA, INIT 1/21/2022 CKD STAGE 5 (GFR <15) T78.40XA ALLERGIC REACTION, INIT 1/21/2022 CKD STAGE 5 (GFR <15)
severe headache, diarrhea, loss of appetite, loss of sense of smell, loss of sense of taste, significant aches and pains, dizziness, chills, sweats  these symptoms began within 12 hours of getting 2nd dose of vaccine, and persist to right now - 3 days after getting shot
day 1 - fever, pain in area of injection (shoulder); day 2 - fever, body aches, headache, fatigue, pain in area of injection (shoulder)
The first vaccine my side effect was that my sinuses opened up.  That could've been due to the anxiety and then relief of receiving the vaccination causing that effect. I had dry mouth and I was thirsty.  The second vaccine EN 6201 I had a headache the next day.  Throbbing headache.  I read not to take Advil or anything right after.   February 09= vaccine February 10=headache February 11= headache didn't go away.  I took Advil in the evening. February 12=headache worsened.  I took Advil in the afternoon.   February 13=I woke up and couldn't see out of my left eye.  There was a fog in central vision.  About an hour later there was a strange aura.  A tornado like tunnel in the central vision started and then shot out from the corner of my left eye.  The aura lasted seconds and then the foggy center dissipated throughout the day.  The headache throbbed and throbbed. I took Advil around the clock every four hours instead of just one a day.   February 14= Full head-ache was gone but sinus throbbed above both eyes. February 16= Eye doctor visit.  Know clue if the vaccine caused the ocular migraine or not. I've never had one before and it is super scary.  My vision hasn't been clear since then and my dry stable MD turned into wet which I don't think has anything to do with the vaccine.  Maybe the headache and the Ocular Migraine was caused by the vaccine.  Who knows.  I just thought I would report it in case other people have the same.  Collecting data is a good thing.
pt recv vax 5SEp95 & the same day pt exp circumoral pruritus & edema;tx DPH & cool compresses;
Sharp, non-radiating chest pain at xiphoid process 10/10 pain worse with inspiration, better with exhalation, unable to lay down, lasting 1.5hours, finally resolved with tylenol and motrin. Two separate instances of this pain, one on 1/18/21 at 1600-1730, and one on 1/18/21 2230-0000.  The second instance the pain was so severe, lead to nausea and one episode of emesis. Initially trialed treatment with antacids but that did nothing to improve the pain. Evaluation by MD on 1/19 at 1300 diagnosed with pleuritic pain secondary to inflammation. No prior history of this, no cardiac history, and no history of GERD.  Other post vaccination symptoms included fever approx 10 hours following the vaccine, nausea, one episode of diarrhea, fatigue, body achs, dizziness, and chills, all of which resolved by 1/18 at 1100am.
Sharp pains in hands and feet. A seasonal allergy to a year-round problem-taking four prescriptions at present. Periods of extreme fatigue-erratic heart beat. Skin blotches. Irritation of scalp, face, arms, legs. Recently discovered anerism in left eye. The follow up states it is difficult to pin point the day and hour of the personal changes of my wellbeing. In some instances the changes were subtle and gradual. I would report them to my personal physician as they occurred but to no avail as to medcial explanations. Possibly the "aging process." Still something wasn't right. I will attempt ot lay out a time frame: 1999 Apirl/May started experiencing periods of extreme fatigue. 2-3 occurrences a month to date. 2000-2003 allergy problems occurred other than the normal hayfever season (July-Sept frost) and have continued year-round to date and am taking four prescribed medications for treatment. 2000 Mid-year-2003 skin blothces on upper body-much like hives and go very uncomfrotable scalp irritation. Using prescribed medication to date. 2000-2003 sleep problems-consulted doctor to no avail. Minor joint pain escalated in hands, feet, shoulders-in areas not associated with any broken bones. Doctor recommended over the counter medication recnetly taken off the prescribed list-on going pain. 2002 April an anerism was discovered in my left eye. Connon in diabetics but I'm not diabetic. Under observation by th clinic again no medical explanation. My life-style has not changed in 20-30 years same home, same type of job, same wife. I work full time, no palns for retirement unless health fails. I have sought medical explanations without results. It wasn't until I read about the LYMErix vaccine being taken off the market and possible side effects did some possible answers appear? Contacting health and related agencies only produced to many similarities in symptoms and coincidences. My intent for taking the vaccine was for preventative medicine purposes, not possible health problems.
I had really bad pain started in the middle of the night pain on my left side traveled from left arm to upper back. I went to ER thought I was having a heart attack. The lymph nodes was swollen had Cardiac work up and Xray(muscular).
pt recvd vax; exp inject site react & high fever; fever lasted 3-4 days;
Information has been received from a physician concerning a 17 year old Caucasian female pt with idiopathic scoliosis who was vaccinated with a 1st and 2nd pediatric/adolescent dose of Hep-B on 5/24/00 and 6/27/00. Subsequently, following the 2nd dose the pt developed tremors of both hands. It was indicated that the 1st dose was administered with no problems. Conflicting follow-up from the physician indicated that the pt has been experiencing tremors since 7/5/00, after her 2nd Hep-B injection. However, on 7/3/00, the pt was seen in the scoliosis clinic by her pediatric orthopedic physician for her normal 6 mo. scoliosis checkup and the pt's mom indicated that the pt was having tremors in her hands. She was last seen in 10/98 and at that time her curves measured 25 degrees and 35 degrees. She is not having any problems. She has no pain with range of motion of her lumber spine with excellent range of motion of the spine. She has no pain with extension. She is having some lower back pain predominantly on the left side of her lower back in the region of her lumbar curve, most likely secondary to a fatigue type symptom. Her mom reported that she is having some tremors in her hands. An upper extremity neurologic exam was performed to evaluate her tremors and it was reported that her exam is entirely normal with full motor strength, sensation and reflexes. It was recommended that she come back in 6 mo. for follow-up care, repeat xrays and possibly consider MRI if there is progression of her scoliosis as well as to evaluate or rule out a spinal cord etiology of her tremors. On 7/6/00, the pt was seen by her family physician and it was reported that the tremors become worse when playing volleyball. The pt was referred to a neurologist for further evaluation. Follow-up information received from the neurologist's office on 10/24/00, indicated that the pt was scheduled for an appointment on 9/11/00 but "never showed up". No further information is expected.
Developed shortness of breath and exertional chest pain within 24 hours of vaccine. Ended up having NSTEMI and 3 vessel CABG a week later.  Will attend cardiac rehab
tingling in left side of body (down to feet/toes). Only on the left side where shot was administered. Tightness in chest.
Around 4 AM I started to experience a fever of 101.2, full body weakness, trouble walking, muscle spasms, irritability, and chills. It was a very strange experience. I took 3 Tylenol at about 7 AM and symptoms started to alleviate around 8:30 AM. The rest of the day I had random body aches, chills, and fatigue. I felt 100 percent by 10 PM on 5/7/2021
Both injections caused fever, chills, migraine like headaches the following day and for 4 days .  Disabling headache.  body aches, lethargy.
Extreme fatigue Shortness of breath Speech difficulty Elevated pulse rate .....all symptoms since Sept 24th 2021 ...all symptoms still current, but worse
Patient complained of redness, rash, and tenderness at the site of injection at the time stated above. She states that the symptoms have begun to resolve on their own as of 05/18/2017 at 9:00 AM.
Vomiting started on 19 April 2021; included fever ranging up to 103F and burning sensation in both legs.  Ability to defecate normally also impacted.  Symptoms also include weakness in legs.  Several doctors visited were unable to diagnosis specific illness causing symptoms.  After patient visit on 23 Apr 2021 included Febrile Illness with Uncertain Cause (Adult).
06/24/2022 Around midnight , I sat in a chair and my heart started pounding. My Cardia monitor confirmed I had A-Fib. I continued to monitor. It has been 2 years since my Catheter Ablation  since I have had A Fib. After 10 minutes, the monitor showed tachycardia, my  heart rate was 130-140 beats per minute- It continued for about 20 minutes .  I have never had tachycardia before, so I did not take the Flecainide I had been prescribed by my doctor.  After a while, I went to the hospital and I had an  EKG that  showed I had A Fib. I had a repeat EKG and a blood test.  The doctor prescribed a medication to slow down my heart because she felt my pulse rate was high. They prescribed Cardizem, an injection. I also had a chest x-ray and a CT to rule out a blood clot in the lung. I had gone back to normal sinus rhythm. My chest x-ray, Ct and bloodwork were all normal. Another EKG was performed, and it was normal. I was discharged. I have an appointment with my cardiologist this afternoon.
Passed out in chair, regained consciousness for 2 minutes, back arched and legs kicked out, paramedics came and administered O2. BP was low (70/35) but rose as O2 was administered.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patients experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not applicable for this report. The caller was a consumer considering getting SHINGRIX vaccination. The caller stated that while researching online, she read some posts from patients that had experienced flu like symptoms for several days to the point where they missed work. No other details available. The caller declined to provide her address. The patient had denied permission to contact their physician.
Fever, Reddened area around right arm, Blistered all in the area of shot, Cellulitis, Md said no to take Td anymore
Suffered several mini strokes and a mild stroke I was hospitalized for on 11/17/2021
All over body hives 11 days from Moderna booster. Started at groin, head, and collarbone. Also, painful chest tightening and closing throat feeling during hive episodes. Hives come and go each day. Incredible itching on welts.