chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching at injection site; This is a spontaneous report from a contactable Other health care professional (HCP) reporting for herself. A 59-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 23Dec2020 at 06:30 PM at single dose for COVID-19 immunization. Medical history included breast cancer (Currently healthy). Concomitant medications included Tamoxifen and vitamin D. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 25Dec2020 patient experienced Itching at injection site. No treatment was received for the event. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient had not recovered from the event at the time of the report. Information about lot/batch number has been requested.
Vaccine recipient received vaccine on 1/5/2021. Within 24 hours they developed right arm soreness and describes arm as feeling heavy. At night they became sweaty and feverish. They took Tylenol. This morning reported that arm was still sore/heavy and they have a headache.
Mild/minimal diarrhea started day after injection and had a sharp pain in side, general malaise (fatigue, headache, etc) for first couple days, on Wed woke up around 4 am and had strong stomach pains, these held strong and consistent for next 24 hrs plus.  This came with diarrhea (~3-6/hour) for the next day plus, vomited 3x, could not sleep due to pain.  Had telemed appointment Wed night was given an antibiotic and something for stomach cramping and advised to go to ER if symptoms persist/get worse for additional testing.  Thursday went to ER as pain was nonstop even with new meds.  Treated in ER, given pain meds inhouse, IV fluids, and released for Inflammatory Colitis and told to continue with antibiotic.   As of a week after start of event, still am not 100% recovered.
SWEATING, SHALLOW BREATHING, VERY WEAK, LIGHTHEADED. It happened a few minutes after receiving the vaccine ( when the patient was waiting 15 minutes) An epipen was administered
At approximately 8pm began feeling slightly nauseated. Tried going to sleep. Had some heart palpitations and what felt like acid reflux/chest pains. Slight headache before bed.  Took some Tums before going to sleep.  at around 10:00 began vomiting horribly. Nausea went away slightly, but returned around 12am. Started vomiting again at 12am and also 2am. Started feeling severe flu like symptoms, severe body aches (especially in legs). Tried taking Tylenol at around 12, but believe it was out of my system once I vomited at 2am. Did not sleep - every time I moved I felt nauseous. Also heart pounding, stomach pain, body aches kept me awake all night. Took Tylenol again at around 7am. Severe body aches kept me in bed all day. Diarrhea.  Severe head ache also gave me sensitivity to sounds and lights throughout the day. Took Tylenol again at around 2pm.  Started feeling somewhat better around 7pm on Friday 2/12. Sat 2/13 felt extremely tired and no energy. Have some lingering diarrhea.
Pt. states that after receiving the 1st dose of Phizer 11/13/2021, started experiencing symptoms 11/14/2021 of headache, nausea, fatigue, and loss of smell and taste. No noted Primary visit/communications. Still experiencing symptoms. Also received the Influenza 1st dose Left arm 11/13/2021.
I (mother of patient ) received the first dose of the Moderna vaccine on Friday June 18th at approximately 01:30pm.   I fed my three month old daughter milk that I pumped from my breasts later that night and put her to bed. When transferring her to her bassinet at approximately 11:30pm, she started a seizure that lasted seven minutes. We were transported to Hospital  where she suffered two more seizures in the early morning hours of June 19th.  She has been a healthy baby with no health conditions prior to these events.
This is an instance of breakthrough COVID-19 disease after which a death occured.  The individual was vaccinated with the Janssen product on 06/15/2021.  The individual had a symptom onset of 11/05/2021 with main symptoms of loss of appetite (not eating) and being lethargic.  The individual tested positive for COVID-19 via an antigen test on 11/05/2021 and was admitted to hospital on 11/05/2021. They remained admitted until their death on 11/17/2021.   Death Certificate details are as follows:  Part I Cause of Death     A: Hypoxic Respiratory Failure     B: COVID 19 Part II Other Significant Conditions:      Acute Chronic Kidney Insufficiency, Coronary Artery Disease, Anorexia
This spontaneous report as received from a Licensed Practical nurse refers to a patient of unknown age and gender. On 29-OCT-2012, the patient was vaccinated with GARDASIL (lot number was reported as 0636AE and expiry date was 09-JAN-2015, route and dose were not reported) that was exposed to 25 degree Fahrenheit for an unknown period of time. No concomitant medications were reported. No adverse symptoms reported. It was unspecified if the patient had sought medical attention. This is one of the several reports received from the same reporter (MARRS # 1212USA000913, 1212USA000914, 1212USA003709, 1212USA003710, 1212USA003712, 1212USA003713, 1212USA003714 and 1212USA004285). Additional information has been requested.
On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and headaches, with nausea and vomiting and a tight chest sensation. The doctor gave the order of solumedrol 80mg IV, TORADOL 30MG IV, TORADOL 30MG Im, Zofran 4 IV and .9 NSS 500mL IV. Afterwards the patient was discharged from the emergency room.
Diarrhea; Full body wheal rash; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (Diarrhea) and RASH (Full body wheal rash) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced DIARRHOEA (Diarrhea) and RASH (Full body wheal rash). On 01-Jan-2021, RASH (Full body wheal rash) had resolved. At the time of the report, DIARRHOEA (Diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment details were not provided.; 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 two days after vaccination, a causal relationship cannot be excluded. Further information has been requested
Immediately following injection, mild tingling and neuropathy throughout left arm. This subsided over the next 4-5 days. There was also the expected soreness in the arm for about 2 days. 7-8 days (overnight) after the injection, a red, itchy, tender, circular rash appeared just below the injection site, about 3 inches in diameter. Along with this was a resurgence of the neuropathy that was most prominent in the left arm, but could also be occasionally felt in the left hip and leg. This lasted, again, for 4-5 days, and the rash faded after about a week. Now, more than 4 weeks after the injection, the rash has not visibly reappeared, but the area is still frequently itchy and occasionally painful. Mild, brief neuropathy occurs with (so far) decreasing frequency.
I started getting itchy, in hands, feet, it was so strange; sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy) and PRURITUS (I started getting itchy, in hands, feet, it was so strange) 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 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced SOMNOLENCE (sleepy). On 24-Aug-2021, the patient experienced PRURITUS (I started getting itchy, in hands, feet, it was so strange). On 18-Aug-2021, SOMNOLENCE (sleepy) had resolved. At the time of the report, PRURITUS (I started getting itchy, in hands, feet, it was so strange) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Lower back and lower extremity pain; Lower back and lower extremity pain; Stiff neck; This is a spontaneous report from a contactable consumer (patient reported herself). A non-pregnant 72-year-old female received BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration to her left arm on 25Jan2021 08.30 AM (Lot number: EL9261) as single dose for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient's medical history included bilateral knee replacement in 2008 and transient ischaemic attack (TIA) in 2017. Allergies to medications, food, or other products: SULFA. Concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior or post to vaccination. On 26Jan2021 05:00 PM, lower back and lower extremity pain, and stiff neck. The events were reported as non-serious. She did not receive any treatment in response to the events. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
The pt inadvertently received a second dose of vax about one year after the first dose and 24 hours following receipt of vax, the pt developed a grossly swollen arm and was hospitalized. The pt was administered intravenous antibiotics and recovered within approximately 3 days.
Chest pain and bloating in the chest area. The underwire in my bra was digging into me because my chest was  so swollen. The pain was in the front of my chest and under my ribs, but did not radiate to my back, just stayed in the front of my chest. It hurt to breathe in and I could barely move without being winded and extremely tired. My chest pain was a 6/10 on the pain scale and lasted for 4 hours before I took 1 Aleve. This was the worst chest pain I?ve ever felt. The pain went away an hour after I took the Aleve and seems to be gone now. I had my husband check my heart rate/rhythm during the event and he said it was normal.
pt had a sz on 17AUG93 for 10-15 mins; an ambulance took pt to hosp; MD didn't feel the sz was due to the MMR; temp was 104.1; pt had a 2nd sz 315AM on 18AUG94 of short duration;
27F pilot in 965AACS who calls to report symptoms related to covid 19 Moderna booster. Pt notes that she received her booster shot on the 7th. that evening she took NSAIDS prior to going to sleep, she fell asleep feeling well but awoke midway through the night or what she feels was awakening and she felt paralyzed, she could hear an alarm in the background but was not able to move or do anything, understandably she was very scared by this incident. She went back to sleep and when she awoke she was febrile to 102, from her aura ring she can tell that the awakening was sometime around 3 am and that her heart rate went up to 138 and stayed there for  at least 1 hour. She experienced left cervical, axillary and inguinal LAD at that time, as of yesterday she still continued to have axillary LAD, she also experience swelling of the arm and a hard red lump on the left arm at the site of injection that persists. She slept for  18 hours of the day after vaccination.  This was her Moderna booster.
Mother reported on 02/10/05 AM that pt had been sleeping since he returned home from college yesterday. She reports that pt refused to get up for dinner last night or for breakfast this AM. She denies fever, pain, n/v, confusion, resp distress or any other symptoms. She reports that this fatigue started after Hep vaccine yesterday and must be related to vaccine, she denies any adverse reaction following 1st HB vac 12/3/04.
Sudden onset dyspnea, chest pain, markedly elevated blood pressure (186/105 taken by paramedics); admitted to Emergency Department for evaluation.
'Severe stiff neck from 2/4 to3/10, with  shoulder muscle aches, vague headache, and slight "fuzzy" feeling and fatigue. By 3/1, I also had thigh and buttock ache with effort and left TMJ pain. On 3/2, I saw Dr. My sed rate was 24. She made a diagnosis of probable PMR and prescribed prednisone. After I single dose, my symptoms almost magically abated and I was almost normal. On 3/11, the only residual symptom with soreness with with extreme neck rotation. On clinical grounds, this confirms the diagnosis of PMR. I assume treatment will continue for several weeks.
COVID (+)  6/26/21 -- > admitted to Medical Center despite being fully vaccinated.
Very strong headaches after the second say to present. Menstrual period on August 20 I had my period on September 1 at night started with heavy bleeding and clots all week. I had a strong current in my head, my vision went dark for a period of 5 minutes, I was dizzy all day and to this day my headaches do not go away.
Spontaneous bowel perforation,Peritonitis, 3 pelvic abcesses drained, by-pass loop ileostomy formed and 2 drains inserted in pelvis near abcesses
Approx. 15 minutes after vaccine had general lethargy and not feeling well, arm discomfort above injection site, discomfort in neck, felt weak, rash developed on face and chest with itching. Patient took Benadryl when symptoms started and another dose of Benadryl that evening.
The patient received the BioNTech covid vaccine and waited 15 minutes in the pharmacy. The patient left with his mom to go shopping in our Walmart store and a few minutes after his 15 minute wait time, the patient developed a heavy nose bleed. We helped patient control the bleed and provided first aid. 10-15 minutes after the onset of nose bleed, it began to slow down and patient felt comfortable to leave the pharmacy.
immed upon inj needle pt became limp, pale, held breath for several seconds; breathing resumed spontaneously although pt remained pale & quit for 2 hr following the vax; RRR40, HR 104, T97.6 02 @ 24 mins administered for 15min
Information has been received from a physician concerning a 10 year old white female who on 19-DEC-1997 was vaccinated SC in the right arm with a first dose of Varivax (lot # 624064/0810E). Nine years after vaccination, on 09-JAN-2007 the patient developed varicella. No further information was provided. Additional information has been requested.
had like a ball form on left shoulder and it's hurting her, where she got the vaccine; it's hurting; This is a spontaneous report received from contactable consumer or other non-health professional reported for patient (sister-in-law).  A 26-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: not reported) via an unknown route of administration in arm left (reported as left shoulder) on 14May2021 11AM (at the age of 26-years-old) as dose 1, single for covid-19 immunization. Medical history included ongoing thyroid. Concomitant medication included ongoing levothyroxine sodium [EUTIROX] Started taking two years ago for thyroid from unknown start and stop date. Family Medical History Relevant to AE reported as it was her aunt, she had the same thing, she got the Pfizer COVID vaccine one, and a ball formed on her shoulder, in the same spot where the patient had hers, but her aunt AE went down. No History of all previous immunization with the Pfizer vaccine considered as suspect and No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations taken within 4 weeks. No Adverse events reported following prior vaccinations. On 15May2021, patient reported to have had like a ball form on left shoulder and it was hurting her, where she got the vaccine, and it was growing more. It was hurting her more when she touches or if she accidentally touches it and she noticed at night, around 11 or 12 after the day of first dose of the Pfizer vaccine. AE did not require a visit to Emergency Room and Physician Office. Patient was not hospitalized. Investigation Assessment was reported as no. Reporter wanted to know is the second dose safe for her sister-in-law, which was scheduled on 04Jun2021. Relevant Tests were reported as no. Patient took Tylenol pills as therapeutic measures for the reported events, and it helped a little bit. Patient reported still she has it. Outcome of the events was not recovered.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information expected.
Initial information received on 22-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient). This case involves female patient of 88 years old (age at the time of report) who experienced it was done as a local rash, while she received vaccine INFLUENZA VACCINE. The patient's past medical history included Cardiac disorder and Ill-defined disorder (The patient has heart problem and a lot of health problems). The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Lethargy (the patient has been hibernating since December because she is afraid to catch the flu, saying she will die if she gets it and said she will die if she gets it). 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. On an unknown date, the patient developed a non-serious it was done as a local rash (rash) following the administration of INFLUENZA VACCINE. It was reported that doctor was training someone in the office and she was the first patient this person administered a flu shot to. She lifted the skin up and put the needle into the skin then went to the other side and put in a PNEUMOVAX vaccine. The needles didn't go into the skin very far since the person pinched up the skin and she immediately broke out in a rash after the needle was removed on each injection. The patient did not know the name of the flu shot. The patient mentioned she was 88 years old. No lab data was reported. Final diagnosis was it was done as a local rash. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for it was done as a local rash.
This started three weeks after the second vaccine. Started with a severe headache, unlike what I've had before. Not a migraine. Pressure feeling like the brain is swollen. Several days of that, followed by one full day of whole body aches. Then followed by three days (on the third day now) of extreme vertigo. Still have head pressure also. I've taken Tylenol and also a OTC sinus pill,   neither are helping.
Redness and swelling on injection site; Redness and swelling on injection site; This is a spontaneous report from a non-contactable nurse (patient). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), intramuscular in the left arm on 06Jan2021 15:30 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medication included colecalciferol (VITAMIN D) and Estro-Aid. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), intramuscular in the right arm on 17Dec2020 at the age of 46-year-old for COVID-19 immunization and experienced mild cough. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 07Jan2021 20:00, the patient experienced redness and swelling on injection site. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious by the reporter.  No follow-up attempts are possible. No further information is expected.
Patient was experiencing burning sensation in calves 4 hours after vaccination but has resolved. The following morning, patient was taken to urgent care for back pain between the shoulder blades (writhing in pain and crying)
Within 2 weeks of having vaccine, I started to get watery eyes and blurred vision. My reading glass prescription changed from 1.25 to 2.25 within two months. hospital closed--because of covid, had to wait to see doctor. Finally saw ophthalmologist. He diagnosed a Subfoveal Hemmorage in left eye causing loss of vision/visual acuity. I believe name is branch retinal vein occlusion (BRVO). I am not positive if this is related--but I have never had any health problems with eyes prior
Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Patient was extremely nervous about receiving vaccine. After patient was calmed down and given the vaccine, she became extremely dizzy and light headed. Patient was instructed to sit and was monitored for various minutes to verify she was okay. After a couple of minutes she was able to stand and wanted to go home.
This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 56, intramuscularly, on Apr 26, 2021, single dose, for COVID-19 immunisation. Medical history included lupus and asthma. It was unknown if the patient was pregnant at vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medications not reported. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On Apr 26, 2021, patient had a very sore arm and fatigue. The events did not result in doctor or other healthcare professional office/clinic/emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of very sore arm and fatigue resolved on an unknown date in 2021. No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.
Started feeling sick at 5:00 pm 8/8. Vomiting and fever up to 105 started at 10 pm on 08/08. Vomited 6 times am 8/9 fever up to 102. 08/11/2005 8:30am patient doing fine.
The patient went to Pharmacy on 9/20/2023 and was given a Flu shot and we received a fax on that day. On 9/22/2023 it was added to the patient immunization record in her chart. She came in for a annual wellness visit on 9/26/2023 and was given a 2nd flu shot. When the log was printed and doing the dose accountability logs. It was found on 9/29/2023 when going through the decrementing for the week. administration was notified and provider notified
Pt described rapid heart, tingling fingers and lips, "warm spots on skin". No SOB or swelling. This incident was not witnessed by health care professionals and pt did not seek medical attention.