chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Colitis; Blood in stool; Stomach pains; This is a spontaneous report from a contactable consumer (patient). A 25-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration, administered in Arm Right on 22Mar2021 16:30 (25-years-old) as single dose for COVID-19 immunization (to go on vacation). The patient medical history and concomitant medications were not reported. Vaccination facility type was Convention Center. Caller reported that he thinks that he got the first dose on 22Mar2021 and is scheduled to get the second dose on Friday, 16Apr2021. Caller reported that on Monday, 22Mar2021 he got the first dose of the Pfizer Covid-19 vaccine.  Caller reported that he went to sleep on 22Mar2021 and woke up starting to feel stomach pains on 23Mar2021.  Caller reported that he felt the stomach pains throughout the day on 23Mar2021. Caller reported that he ended up going to the emergency room due to the stomach pains.  Caller also reported that while using the bathroom, there was blood in his stool. Caller reported that when he went to the emergency room, he was diagnosed with colitis on 24Mar2021.  Caller reported that his discharge paperwork from the emergency room states that colitis can happen from vaccines.  Caller reported that the emergency room staff could not rule out the Covid-19 vaccine as the cause of the caller's colitis because the vaccine is so new. Caller reported that he was prescribed antibiotics for the colitis, which helped. Caller reported that the stomach pains stopped in Mar2021 (also reported as about 5 days afterward he got the antibiotics on Wednesday, 24Mar2021). Caller reported that he is no longer experiencing blood in his stool at all.  Caller reported that he had blood in his stool on the night of Tuesday, 23Mar2021 and the morning of Wednesday, 24Mar2021.  Caller reported that the blood in his stool resolved around 4-5 days after beginning the antibiotics prescribed for his colitis. Caller reported that his colitis resolved completely about 4-5 days after beginning the antibiotics, around Friday 26Mar2021 or Saturday 27Mar2021. Caller reported that he had not been able to find his vaccine card and he did not have anything with the product NDC number, lot number, or expiry date. Caller reported that when he went to the emergency room, the emergency room staff took blood and did a CAT scan on 24Mar2021.  Caller reported that he did not know the results of these investigations, but that the emergency room staff said everything looked normal. The patient underwent lab tests and procedures which included CAT scan: unknown results (everything looked normal) and Unspecified lab work: unknown results on 24Mar2021. The outcome of the events was recovered in Mar2021.   Information on the lot/batch number has been requested.
both sides of my groin were hurting when walking; 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 83 year-old male patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Batch/Lot number: unknown) at the age of 83 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 13Jan2021, when the patient was 83 years old, for Covid-19 Immunisation. The following information was reported: GROIN PAIN (non-serious), outcome "not recovered", described as "both sides of my groin were hurting when walking".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu shot given at 9AM. Rash/hives began at 10:30 PM. BENADRYL taken 10:45 PM. Rash resolved 11:15 PM.
Patient came in to receive the 2nd dose of the COVID vaccine, the consent form was not verified properly and  vaccine was administered as the 2nd vaccination instead.
Aggravated my neuropathy,  more numbness and pain, Aggravated my arthritis in shoulders, hips, knees, Muscle pain
Last dose of Vivotif 6/1/07. 6/4/07 developed urticarial rash neck, underarms, wrist, groin popliteal spaces. TX Loratidine 10mg, Chlortrimeton tonight 8mg then repeat Loratide 10mg.
Seven patients were administered an improperly stored dose of VARIVAX; No adverse effects were reported; This spontaneous report was received from a Registered Nurse concerning to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose was not reported) lot # N034557, the expiration date: 05-DEC-2019, subcutaneous for prophylaxis.  The sterile diluent was properly stored. No adverse effects were reported.  The temperature of excursion registered was 5.5 °F, for 2 hours and 15 minutes. The call was made due to a data logger and there was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA008023:
Information concerning 13 children who were vaccinated with one dose of varicella. Subsequent to receiving the vaccine, 10 of the children developed chickenpox.
After receiving the flu shot I almost right away felt weird, a little dizzy, I felt as though my eyes couldn't catch up with what I was looking at, a little blurry eyed I can call it. So I hung out a little in the doctors office, I was told it was normal. I left the office feeling a itchy where I received the shot, by time I got home I was all hived out on my right upper arm where I got the flu shot, my face broke out as well in hives, I then had trouble breathing, tight throat, tingling numb like tongue, hives, dizzy, swollen painful upper arm. The next day the same as above but I then developed a knot on my right arm that kept getting bigger.
Information has been received from a physician concerning a 26 year old female who in May 2010, was vaccinated with the second dose GARDASIL. The patient complained that the second dose hurt more than the first. The patient received GARDASIL in her left arm and still complained of pain at the injection site. The patient did not seek medical attention. This is one of several reports received from the same source. Additional information has been requested.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299815, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299805, 2018SA299794 and 2018SA299809 (cluster). This case involves 82 years old female (height reported as 63.5) patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pt vaccinated with MR experienced rash and adenopathy for 7 days starting 10 days after MR vaccine inject
pt c/o swelling lt side of jaw/ear & sl to lt side of face; tightness of chest, palpita; also CP & back pain w/SOB; VS P100 observed to have flushing to face;
An expired Covid-19 pfizer vaccine was administered to the patient on 4/28/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5/9. Patient does not plan to get revaccinated at this time.
Allergic Angioedema noticed about 18 hours after administration of H1N1. No resp sx. Rx ZURTEC. 12/4 & 12/23/09:  Primary care records received for dates of service 9/18/08 to 12/7/09: Dx:  Allergic angioedema  Presents with swollen lips, tx. Zyrtec.  On 12/7/09 pt. presented with geographic tongue, given reassurance.
This spontaneous report as received from a medical assistant refers to a 2 month old patient of unknown age. The patient's medical history was not reported. On 20-AUG-2014 the patient was vaccinated with improperly stored ROTATEQ (dose and frequency were not reported, lot # J004944 and expiry date: 12-NOV-2014). No adverse symptoms were reported. The temperature excursion for the ROTATEQ was a supported excursion with in-house stability data. No product quality complaint (PQC) was reported for ROTATEQ. This case is linked to 1409USA010141, 1410USA009191, 1410USA009192, 1410USA009193 and 1410USA009194 (same reporter link). Additional information has been requested.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 26-JAN-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Wife called 10-15-03 and stated that patient right arm was red, swollen, hot and painful from deltoid to elbow.  Advised the use of heat and ibuprofin and call doctor if not better tomorrow.  Called 10-16-03 and is less painful, less swollen, and red.  Wife states it is much better than yesterday.
Received TD injection 4/12/04 right deltoid. Sunday 4/18/04 noticed redness right deltoid that radiated down. Upper arm became itchy. Rash developed on pelvic area. Diagnosed as shingles by doctor.
Pt complained of large 4" by 4" red imflamed wheal at injection site, painful and swollen.
Patient came to the pharmacy on 10/28/2017 with complaints of shoulder pain from the injection. He states the pain has been getting progressively worse since the shot. He contacted his PCP and was prescribed oral steroids and NSAIDS.
3 days after vaccine given, patient got sores in mouth. Diagnosed 1/21/19 at dental office as oral shingles. Treated w/acyclovir 200 mg 2 PO TID x 10 days. Patient has pictures if needed.
The following day he complained of severe headaches. Sensitive to noise. 3 days later severe leg pain. He refuses to stand or walk on his legs. The slightest movement of his leg has him screaming and crying in pain.
Pfizer-BioNtech COVID-19 Vaccine EUA:  Pt brought up after rapid response to COVID vaccine. Pt c/o throat itching, back itching, hot, and flushed. Denies diff swallowing at this time. Upon arrival to ED, AOx4. NAD. Flushed/WD. GCS 15. Ambulates independently with steady gait upon arrival. Pt. has documented allergies to Latex, ciprofloxacin and Amoxicillin-pot Calvulanate.
received vaccine at health department on 02/25/2021 and presented to this reporters facility ED on 03/07 with dizziness and generalized edema.  Seen and treated in ED for CHF and UTI.
Prior to vaccination  patient informed RN about anaphylactic reactions from different medication as mentioned above on her allergies. Patient was instructed to sit by the vaccination table across the RN table for better observation with close proximity. 20 minutes later noted patient was starting to cough and trying to clear her throat and fanning herself. Few minutes later she complained of itchy throat and when asked if she had the same feeling when she has anaphylactic reactions she claims this is different. Right away we sent her to ER by wheelchair. We have been calling ER and they said she was still under observation. At 4;15 pm RN went to ER to check on her. Was told she was discharged home . Called her number on the record but no response.
his sore arm after taking the second dose of the Pfizer Covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administration date 21Apr2021 10:20 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Apr2021, outcome "unknown", described as "his sore arm after taking the second dose of the Pfizer Covid-19 vaccine".  Additional Information: Patient wants to know if he can take any pain killer medication Tylenol or Advil for his sore arm. patient stated he received his second shot yesterday at 10:20am and his arm is a little sore he stated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mental fogginess; Severe vertigo; rocking; dizziness; disorientation; Moderate injection site pain; fatigue; This is a spontaneous report from a contactable consumer (patient). This 32-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8730), via an unspecified route of administration in the right arm on 30Mar2021 at 04:30 PM at single dose for COVID-19 immunization. Medical history  and concomitant medications were unknown. The patient was not pregnant. The patient had no other vaccine in four weeks, no other medications in two weeks. The patient experienced severe vertigo (rocking and dizziness), disorientation, mental fogginess, moderate injection site pain and fatigue; all on 01Apr2021 at 06:00 AM. Treatment was received for events including medication and rest. Event resulted in [Doctor or other healthcare professional office/clinic visit]. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of the events was not recovered.
Symptoms started at 10pm with strong fatigue. I woke up at 4am with severe chills and cold sweats, body aches, nausea, and vomiting. That continued until 6am when I went back to sleep. Woke up at 12pm with a headache, fatigue, chills, body aches.
temp 101 deg at 9:30 pm-this am 104 degrees feels achey all over today- no n/v/d Tylenol no help
C/o worsening fatigue. Doesn't feel like herself - sometimes out of body experience. Fatigue is to the point where she feels she needs to sleep which is new. Has chronic insomnia and difficulty staying asleep. Sometimes feels dizzy and lightheaded. Has loss of appetite.
Pt reported L-sided arm pain inferior to injection site. Pt was monitored for 30 minutes and did endorse improvement with her arm pain without intervention.
achiness; little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness) and VACCINATION SITE PAIN (little sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL, MULTIVITAMIN [VITAMINS NOS], VITAMIN D NOS, FISH OIL, METOPROLOL and MAGNESIUM for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (achiness) and VACCINATION SITE PAIN (little sore arm). At the time of the report, PAIN (achiness) and VACCINATION SITE PAIN (little sore arm) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2021-377032, MOD-2021-377060 (Patient Link).
w/in 12hr of vax pt devel an inj site rxn characterized by tenderness & a 2inch by 2 inch welt;pt was improving as of 29OCt;this is 1 of 5 pt, out of 12 vaccinees, to exp this event;
01/24/22 presents to ED for "Breathing Problem". PMHx of "T2DM, HTN, asthma, stroke"
Approximately 10 minutes after receiving the vaccine, the patient passed out.  She was sitting outside the pharmacy, waiting for 15 minutes as instructed. She was only out for a few seconds and had regained consciousness by the time I reached her.  She was given a drink to sip on and she waited for another 20 minutes before leaving.  We repeatedly asked her how she was feeling and she said better and said she was ok when she left around 6:30pm
while mom bathing pts eyes, pt became apneic lasted 30 seconds; cyanotic & limp; life squad recorded pulse oxy 70%; mask 02 given w/good response; 02 @ ER 99% room air; adm hosp for poss sepsis;
lt arm elbow to shoulder swollen, blotchy & sore to touch x 3 days p/inj
3 days post vaccination developed hives to chest, vomiting, diarrhea, and headache.
Infant developed hives 22 hours post immumizations on neck, trunk, and legs.  No swelling of lips nor difficulty breathing.  Consult to allergy clinic
Reports He ETOH abuse and low immune system. On 3/10 he requested following TD, Flu, Pneumonia vaccine, even though he is only 22 YR old. On Sat 3/11, client reports awakening with red, swollen, tender left arm with limited ROM. Around 2pm, noted fever 102.4, and feeling achy all over. Saw DR who prescribed Z Pac 5day and Ibuprofen. 3/14 Still C/O some tenderness, and swelling able to move arm better, but still not full ROM.
Information has been received from a physician concerning a 16 year old female who is not pregnant who was vaccinated with Gardasil. Subsequently, the patient experienced injection site pain about one week after vaccination. The pain diminished for a while and then returned as significant shoulder pain. She had no other vaccinations at the same time. She has had no treatment so far. She had sought unspecified medical attention. Additional information has been requested.
Uncontrollable itching all over body, fever, bruises all over body. Itching started within hours of receiving  the vaccine. Took Claritin, took hot bath and tried sleeping but was difficult. By Sunday, 4/11, rashes and bruises began to go away.
Pt had red fluid filled area the size of a fifty cent piece just below injection site area around  that red but not raised.
Redness, warm, tender at injection site (L deltoid). Redness measures 60mm x40mm.  Firm area measures 50mm x30mm.  Itching anterior upper arm.  States she is not feeling well and is very fatigued.
Headache; Fever; I was so tired after I got the first shot; I was feeling sick; This is a spontaneous report from a contactable consumer (patient). A 49-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EBK33, UPC/ NDC number / Expiry Date of COVID Vaccine: Unknown), via an unspecified route of administration on 02Apr2021 (at the age of 49 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in Apr2021, the patient had experienced headache and fever, was so tired after the first shot, for next sixteen hours and felt sick. The patient took Paracetamol (TYLENOL) and everything was perfect. On an unknown date in 2021, the outcome of the events was resolved.   Information on Lot/Batch number is available; Further information has been requested.
Bone pain; sore; o2 stat - 92; waking up at night; loss of taste; severe headaches-headache pressure was persistent; low grade fever 100.5; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain), PAIN (sore), SLEEP DISORDER (waking up at night), AGEUSIA (loss of taste) and HEADACHE (severe headaches-headache pressure was persistent) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 22-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021 at 7:00 PM, the patient experienced BONE PAIN (Bone pain), PAIN (sore), SLEEP DISORDER (waking up at night), AGEUSIA (loss of taste), HEADACHE (severe headaches-headache pressure was persistent), PYREXIA (low grade fever 100.5) and OXYGEN SATURATION DECREASED (o2 stat - 92). At the time of the report, BONE PAIN (Bone pain), PAIN (sore), SLEEP DISORDER (waking up at night), AGEUSIA (loss of taste), HEADACHE (severe headaches-headache pressure was persistent), PYREXIA (low grade fever 100.5) and OXYGEN SATURATION DECREASED (o2 stat - 92) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: 100.5 07:00 PM. On 22-Feb-2021, Oxygen saturation: 92 07:00 PM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included acetaminophen 1000mg for headaches.
38-year old-female came into the clinic today with concern that the injection site of the tetanus that was given to her yesterday had redness and itching around the area. Denies any history of allergies to Tdap vaccine. Denies any shortness of breath or any generalized pruritus. Patient also here to review her lab results.