chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stomach Pain; Vomiting; Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 4-year-old male patient received BNT162b2 (BNT162B2), on 01Jul2022 at 17:45 as dose 1, single (Lot number: FL8095) at the age of 4 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Premature Birth" (unspecified if ongoing); "Pyloric Stenosis" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; CLARITINE; MELATONIN. The following information was reported: DIARRHOEA (non-serious) with onset 02Jul2022 at 01:15, outcome "not recovered", described as "Diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 02Jul2022 at 01:15, outcome "not recovered", described as "Stomach Pain"; VOMITING (non-serious) with onset 02Jul2022 at 01:15, outcome "not recovered". The events "stomach pain", "vomiting" and "diarrhea" required emergency room visit. Therapeutic measures were taken as a result of abdominal pain upper, vomiting, diarrhoea.  Additional information: Other medications in two weeks included Multivitamin, Vitamin C, Claritin 5mg, Meletonin. Treatment of adverse events was prescription of Zofran. The patient had no known allergies to medications, food, or other products. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Moderna COVID vaccine   Injection was administered in the left glúteas medius: A week after vaccine noticed at site of injection a 3 diameter of induration w itchiness , w  0.5 diameter having redness in addition. The whole left upper side of my dorsalgluteal side and hip are notably  swollen.  Pain 3-4/ 10 when indurated  site is touched.
The patient presents with 77 year old male with history of CAD, HTN, HLD, AAA on Plavix, MI, angina, COPD, CVA, and enlarged prostate presents to ED with c/o weakness and multiple falls x1 week. Sts he woke up to use the restroom at 0400 and started leaning forward and got caught between the toilet and the wall. He c/o left sided trunk pain that's exacerbated with coughing and palpation. EMS was called to assist the patient but he refused to be transported. Patient is on 2L oxygen at night secondary to COPD.  Patient states he always has a decreased urinary stream.  Also states he always has a cough..  The onset was 1  weeks ago.  Incidental finding--Covid.
it felt like she was having a heart attack; anaphylaxis; her blood pressure was 160/110; she had a rash on her neck and chest; chest pain; heart palpitations; chest pressure; her arm was numb; her heartbeat was ridiculous/heartrate went over 150; dizziness could be a symptoms of this type of reaction and she stated she was dizzy; She swelled up the first time but yesterday it felt like she was having a heart attack; She swelled up the first time but yesterday it felt like she was having a heart attack; she got the shakes; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history included Drug allergy (had lot of drug allergies) and anaphylaxis (it was different than what she experienced yesterday). The concomitant medication was not reported. The caller stated she had the first dose of the vaccine and was in the emergency room with chest pain, heart palpitations, and her blood pressure was 160/110 all day. They gave her nitroglycerin and Benadryl because she had a rash on her neck and chest, had chest pressure, her arm was numb, and her heartbeat was ridiculous. They got it under control, and she was sent home. She stated she read that if you have had a severe allergic reaction you should not get the second dose and saw that dizziness could be a symptom of this type of reaction and she stated she was dizzy. She asked what would be considered a severe allergic reaction. she was scared about getting her second dose. She asked how many other people have had a rapid heartbeat, dizziness and a rash and still got their second dose? Is there treatment if you get the second dose and have a reaction? How many got the second dose with these symptoms and survived? How does she know she will live through it if she gets the second dose. It was also reported that patient experienced anaphylaxis. She swelled up the first time but yesterday it felt like she was having a heart attack. She stated the HCP wants her to go to an allergist. She said when they gave her Benadryl she got the shakes and her heartrate went over 150 with this medication. She asked if the second was worse than the first dose. Therapeutic measures were taken for the events it felt like she was having a heart attack, anaphylaxis, her blood pressure was 160/110, she had a rash on her neck and chest, chest pain, heart palpitations, chest pressure, her arm was numb, her heartbeat was ridiculous/heartrate went over 150, dizziness could be a symptom of this type of reaction and she stated she was dizzy, She swelled up the first time but yesterday it felt like she was having a heart attack. The outcome of the events was unknown  Information on the lot/batch number has been requested
Irregular mensuration, spotting, chronic headache, dizziness, fatigue, loose bowl movements, upset stomach, hot flashes, loss of appetite, lower abdomen cramping.
Full Body itching; mouth burns; intense joint aching; no sleep for 3 nights; This is a spontaneous report from a contactable consumer (parent).  An 83-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6202, expiration date was not reported) via an unspecified route of administration, in right arm, on 26Feb2021 14:00 (at the age of 83-years-old), at dose 1, single for covid-19 immunization. The patient had no medical history and no known allergies. There were no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. The patient experienced full body itching, mouth burns, intense joint aching, no sleep for three nights on 27Feb2021 20:00. No treatment was administered for the events. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
After the first Covid shot I noticed a slight ringing in my right ear, which went away. After the second Covid shot, I developed tinnitus in my right ear. I went to see my doctor and he said he can give me steroids or wait and see if it improves by itself. The tinnitus has improved and is now not always but only temporary.
Case number PHEH2016US026693, is an initial spontaneous report received from a consumer on 12 Oct 2016. This report refers to an unknown age of female patient. Past medical history was not reported. Current conditions included as immune issues. Concomitant medications was not reported. She was vaccinated with influenza vaccine (unknown whether seasonal or pandemic, manufacturer and batch number: not reported) on an unknown date. On an unspecified date, the patient experienced sick every year. The outcome of the event was reported as unknown. Seriousness and causality of the event were not reported.
Pt had a large bowel mass requiring surgery and was positive for COVID-19 prior to the OR.
Rash maculopapular with some target lesions. Started 1 day post vaccine. No treatment needed. Improving
Pt reported with the 1st dose his left arm as sore for a couple of days. Pt reported with the 2nd dose, he felt feverish but sxs has subsided. On 4/29/2021, pt reported he felt sluggish and warm. Currently he reports there's a red patchy appearance at the injection site (left arm) that looks ~3 inch in diameter, and he reports he can feel a lump when placing his hand over the injection site area and it feels warm to the touch. Pt also reports that he can feel some pain with arm movements, but not at rest. Advised pt ADEs are more common with 2nd dose and ADEs usually occurs within the first 3 days and should resolve after 1-2 of onset. Recommend pt can place ice pack for 15 minutes on and 15 minutes off as need to help with the warm sensation in the left arm; can also take Ibuprofen PRN for pain. Recommend pt to stay hydrated and wear loose fitting clothing to keep the area cool. Recommend if symptoms worsen or intensify to contact MD or go to urgent care to get evaluated.  Patient feeling much better, no longer has pain at injection site still has lump and redness but both have decreased in size. There were some itchiness to site which was alleviated with Benadryl, still has slight warmth when touched. Recommended to follow up with provider if symptoms worsen.
The next day after receiving the Covid vaccine injection in my left arm, I had the typical muscle pain.  That subsided within a day or two.  But I am experiencing numbness and tingling throughout the entire length of my arm.  It is not severe and I am still able to conduct my work and daily chores, but it is very concerning to me.  It is now 5 days later, and the numbness is not any better.  My left pinky finger is the worst out of all of my digits.  I'm not sure if they somehow hit a nerve during the injection or if this is a side effect of the shot.
Redness, stinging, itchiness, swelling, pain. Golf ball sized lump after 2 days.
Patient arrived at the site to get a second dose of COVID-19 Vaccine. The patient informed the site administrator that she had received her first dose in January, but did not have any record of receiving the dose. The site administrator vaccinated the woman with the Pfizer Vaccine without checking the ADPH's IMMPRINT system. Upon entering information into the database after the vaccination occurred, the data entry consultant informed the vaccine coordinator that the patient received the Moderna vaccine on 01/28/2021 and the Pfizer vaccine on 05/19/2021. The patient has not contacted the site administrator or vaccination clinic with any other health issues related to the mixing of different brands of vaccines.
Red induration 4-5cm for 48 hours. Wheezing, bruising. Wheezing 2 days.
LETHARGY; DECREASE APPETITE, POOR SLEEP X WKS, POSITIVE COVID TEST; ACUTE HYPOXEMIC RESPIRATORY FAILURE
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored M-M-R II (strength, lot#, expiration date, dose and route were unknown0. the temperature excursion for M-M-R II was not supported with in-house stability data. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Injection sites were also sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: EW0150) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep Issues" (ongoing), notes: Started years ago; "Sleep apnea" (ongoing), notes: Started about 12 years ago; "Restless leg" (ongoing), notes: Patient has had for most of his life; "Penicillin Allergy" (unspecified if ongoing), notes: He has a history of having severe allergic reactions to the Penicillin family of medication. Concomitant medication(s) included: PENTAZOCINE taken for restless legs syndrome (ongoing); ATENOLOL taken for hypertension, start date: 2018 (ongoing); ATORVASTATIN taken for blood cholesterol, start date: 2020 (ongoing); ESZOPICLONE taken for anxiety (ongoing); BUPROPION taken for anxiety, sleep disorder (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Apr2021, outcome "unknown", described as "Injection sites were also sore".  No follow-up attempts are possible. No further information is expected.
Severe body tremors, escalating blood pressure and heart rate at one time. Then another time, blood pressure and heart rate drop way low and I pass out. Extreme fatigue and confusion. In CCU once and in ICU twice in addition to other days admitted. Bed ridden for most of this time. Cannot drive!
Stem Cell Transplant; This case was reported by a pharmacist via call center representative and described the occurrence of stem cell transplant in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced stem cell transplant. On an unknown date, the outcome of the stem cell transplant was unknown.   It was unknown if the reporter considered the stem cell transplant to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The pharmacist reported that a patient had a stem transplant after receiving the first dose of Shingrix.  The patient did not know what the indication for the stem cell transplant was or if the disease started before or after Shingrix. The reporter consented to follow up.
pt recv vax; rt leg swelling from hip to knee; hot to touch; T 102; called MD & wa advised to double dose advil; high pitch scream;
only 1 other person in the hospital who responded with reaction and having blisters head to toe; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLISTER (medically significant), outcome "unknown", described as "only 1 other person in the hospital who responded with reaction and having blisters head to toe".  Additional information: Only 1 other person in the hospital who responded with reaction and having blisters head to toe. No one else in the whole hospital that was vaccinated had any of these reactions. Was just the 2 of them.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available,The casual association between the reported event "BLISTER" and suspected drug cannot be completely 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.
pt felt dizzy going back to classroom p/vax;pt fell to floor & was incontinent;pt gray & was bluish around the lips;breathing was labored;
Patient reported she has redness and swelling at the injection site and by 7pm Friday evening, she had aches, pains and a fever that peaked at 100.9 degrees.  She used ice packs for swelling and Tylenol for the fever.  The fever went down to 97 degrees by Saturday morning at 6:30 am.  She reported she still had some aches and pains but they were getting better and were almost resolved.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 17-MAR-2015, the patient was vaccinated with the first dose of VAQTA (dose and lot # not reported) intramuscularly and on 24-MAR-2015, the patient received the second dose of VAQTA (dose and lot # not reported) intramuscularly. No adverse experience was reported. Additional information is not expected. There is no permission to contact the physician.
This spontaneous report as received from a medical assistant refers to a 18 year old patient. On January 2000, at the age of 11 months the patient was vaccinated with VARIVAX (lot #, expiration date, dose and route of administration were not reported) for prophylaxis. On an unspecified date in 2009, the patient has received second dose of VARIVAX (lot #, expiration date, dose and route of administration were not reported) for prophylaxis. On 15-JUN-2017, the patient has received third dose of VARIVAX lot # L029466, expiration date 06-SEP-2017 and as reporter refers "it was given intramuscularly rather than subcutaneously". No adverse effects were reported.  Additional information has been requested.
Neck and arm pain shooting down to the hand; Neck and arm pain shooting down to the hand; Severe Headaches; Twitching of left hand; Blurry vision; Fog headed; Unable to focus; Body and joint pain; Body and joint pain; Memory loss; Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 14Apr2021 at 13:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included iron chew (MANUFACTURER UNKNOWN) and vitamins (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took prochlorperazine edisylate (COMPAZINE) and metoclopramide (REGLAN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 17Mar2021 at 13:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 14:00, the patient experienced neck and arm pain shooting down to the hand, severe headaches, twitching of left hand, blurry vision, fog headed, unable to focus, body and joint pain, memory loss, nausea, vomiting and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events neck and arm pain shooting down to the hand, severe headaches, twitching of left hand, blurry vision, fog headed, unable to focus, body and joint pain, memory loss, nausea, vomiting and diarrhea was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. Information regarding concomitant medications, concurrent conditions and medical history was not reported. On unspecified dates in April 2015, reported as since 03-APR-2015 and since 24-APR-2015, unspecified patients were vaccinated with (Merck) VARIVAX (dose, frequency, lot number, expiration date were not reported). The (Merck) VARIVAX was exposed to temperatures outside of the recommended range. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Days before patient could stand/walk on her own d/t pain in the feet and general unwell feeling.  Slight fever. No appetite - unusual for patient.
Threw up foam and saliva in middle of night. Felt like I was choking, woke from a sleep coughing and spit up foaming mucus. Right leg was tingling as well.
Since I have received the vaccine-- I am now having  2 periods a month.  Sept 2021: started period on 9.11 & again on 9.20. Oct 2021--Started period on 10.14 & again on 10.28. Nov 2021-- I started on 11.13 & again on 11.28.  I have never had 2 periods a month.
Within 24 hours, she developed enlarged left axillary lymph nodes, pain and swelling to left arm, which lasted for several days. She became progressively fatigued. 4 days after vaccine she had a weird "episode," which in hindsight was likely a TIA on 12/31/2021. She had a right cerebellar stroke without a known cause.
After receiving the Pfizer Covid adult Immunization 1st dose, the patient said she was experiencing abdominal and back pain, dizziness, heavy breathing, shortness of breath, and cold hands.  According to her husband, she has had other vaccines in the past without problems.  He said she was nervous getting the Covid vaccine b/c of reports of adverse effects.  After talking to the patient and her husband, she said we should call emergency services.  I called emergency services, and the paramedics came a few minutes later.  They took the patient outside on a stretcher.
At 03:00 AM, on 11/15/01, the pt noted hives and complained of itching on her face, neck and upper torso. Rx'd Claritin D 1 QD PO.
This spontaneous report as received from a Registered Nurse regarding a 4 year old child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 17-SEP-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
Symptoms of and diagnosed with ulcerative colitis in November 2007 requiring 2 hospitalizations for exacerbation since 11/2007 7/14/08-records received-office visit 7/31/07-C/O tired. 11/28/81-DX ulcerative colitis. Loose stools and abdominal spasms. Tired weak.  12/24/07-GI consults-history of ulcerative colitis in remission. Presented with abdominal pain, diarrhea, anemia and hypoalbuminemia. Weight loss, joint pains. 2/18/08-Continues in remission. Flu symptoms 10 days ago. Intermittent shoulder, ankle and wrist pain. 5/30/08-Sick visit, off steroids. Three days prior increasing stooling and minor bleeding and severe cramps.  7/21/08-records received for DOS 5/31-6/4/08-DC DX: ulcerative colitis flare. Presented with 2 weeks of abdominal cramping and 3 days of diarrhea tht had become bloody. Nausea.
Minor headache; Gland swelling in his neck; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Minor headache) and LYMPHADENOPATHY (Gland swelling in his neck) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ALLOPURINOL for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced LYMPHADENOPATHY (Gland swelling in his neck). On an unknown date, the patient experienced HEADACHE (Minor headache). At the time of the report, HEADACHE (Minor headache) had resolved and LYMPHADENOPATHY (Gland swelling in his neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Treatment for the event headache was done with paracetamol.
This is a 97 year old, frail, elderly male, patient of Dr. with past medical history significant for CAD, s/p CABG, HTN, HLP, Hypothyroidism, Barretts Esophagus, Depression, Bells Palsy with residual Left side facial droop/weakness, who presented to the ED with complaints of SOB, CP, Cough, poor po intake. Apparently this started several days ago per his family.