chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe stomach pains; Diarrhea; This is a spontaneous report from a non-contactable consumer and a contactable consumer, pfizer employee.  A 23-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 04Oct2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. It was unknown whether the patient received other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 04Oct2021, the patient experienced severe stomach pains and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe stomach pains and diarrhea were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Facial erythema (blotchy) and periorbital swelling left to right, occurring 2-3 hours of vaccines. Resolved with Benadryl dose. Also, dx'd sinusitis the same day but no antibiotic given.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. A 37 year old black male medical technician who died of a heart attack in February 2000 in the midst of an anthrax vaccine controversy at the base. The military vehemently denied any connection between his death and the anthrax vaccine, and it is unclear if a report was ever filed.
Initial report received from a consumer who is also the patient's parent on 08 February 2013. A 2-month-old male patient, whose medical history and concomitant medications were not reported, had received a dose of PENTACEL vaccine (lot number: unknown, number in series, route and anatomical site of administration were not reported) and a dose of Hepatitis B vaccine (Manufacturer: unknown, batch number, number in series, route and anatomical site of administration were not reported) on 04 December 2012. On an unspecified date shortly after vaccination, the patient developed eczema which continued till the date of this report. The reporter was not sure whether the eczema was related to PENTACEL vaccine. The patient's physician was evaluating for "food allergies or autoimmune issues". Corrective treatment and relevant laboratory data were not reported. The patient's outcome was not recovered. Documents held by sender: None.
Severe local reaction - hives and swelling from elbow to shoulder. Slightly warm to touch, very painful. No fever.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Additional Details: About 15 minutes after receiving the Moderna shot, patient walked up to a pharmacyand fell and blacked out for a few seconds. With permission, patient was then laid flat on the ground and elevated his legs/feet on a chair.  We called 911 and epinephrine was acquired. Patient was provided water. Paramedics came and asked the patient questions. Patient was okay so they did not take him in. Patient was asked to stay another 15 minutes and afterwards, patient said he felt good and left.
The patient experienced common symptoms for 3 days (fever, muscle aches, headache, itchy and swelling at the injection site) then on day 4 felt completely fine, by day 5 the patient developed itchiness in her ankles, by day 8 (today) her ankles are now extremely itchy and have a rash.  I encouraged her to take Benadryl and contact the prescriber on Monday morning.  I encouraged the patient to speak with her doctor so they can document and treat if necessary.
Immediately began to feel a headache, dizzy and nauseated.  The doctor on site had me lie down on the floor. Was starting to feel better so was able to sit up in a chair for about 15 minutes. Another wave of dizziness and nausea came over and was lying on the floor again. It was hard to breathe, but oxygen and HR were good. The doctor tried to give me juice to see if it was my blood sugar going low, but afterward, I still felt dizzy and nauseated. It was still hard to breathe. It felt like something was sitting on my chest. BP was elevated, oxygen levels were good, HR was good but I started to get a cold chill where my teeth were chattering. At that point (about 45 min to an hour) the symptoms had not gone away and the ambulance was called. Was transported to the local hospital where I received a liter of saline and Zofran for nausea.  BP was high, but oxygen levels and HR were good. The heart monitor showed no signs of arrhythmia or tachycardia so I was discharged. The doctor believes it was a side effect and not an allergic reaction.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Facility consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Facility is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
On the first day of getting the vaccine, I had wheezing. The next day I couldn't wake up, I was very weak. I do not remember much from the next day. I slept the rest of the day. I felt really weak and I had a fever just under 103 for several days afterwards. I had diarrhea when I got up in the morning for the next 3-4 days. I lost my appetite, could only eat bland food. I had a burning feeling on the left side of my colon so my doctor sent me the ER.  I was in the ER for 8 hours, gave me an IV.
Severe allergic reaction; Arm swelled up; Red on deltoid; Itchy on deltoid; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergic reaction (Verbatim: Severe allergic reaction), swelling arm (Verbatim: Arm swelled up), erythema of extremities (Verbatim: Red on deltoid) and itchy upper limbs (Verbatim: Itchy on deltoid). The outcome of the allergic reaction and swelling arm were not reported and the outcome of the erythema of extremities and itchy upper limbs were resolved (duration 1 month).   It was unknown if the reporter considered the allergic reaction, swelling arm, erythema of extremities and itchy upper limbs to be related to Shingles vaccine.     It was unknown if the company considered the allergic reaction, swelling arm, erythema of extremities and itchy upper limbs to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR067384   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by the patient via interactive digital media. The patient had severe allergic reaction, arm swelled up and was red and itchy on deltoid for a month. Second time the patient took Benadryl just in case.  When it worse off my face was swollen. Went immediately to get medical help.  The patient would not ever get another vaccine for this. The follow-up could not be possible as no contact details were available. For tolerance of 2nd dose refer case US2023AMR067384.; Sender's Comments:  US-GSK-US2023AMR067384:Same patient
Localized fine red rash on right arm at injection site, and rash continued to spread over entire body.   Rash became open sores - which were worse on arms, torso, groin area, legs - to include both feet.  Last area affected was ears and scalp.  Seen by local doctor, diagnosed initially with eczema - treated with protopics.  Rash continued to worsen with no relief from protopics.  Had several follow up visits with local dermatologist- to no avail. Patient was directed to a facility for further evaluation.  Was seen by a dermatologist- who referred patient to a rheumatologist due to concerns about new onset of possible auto immune issues secondary to COVID vaccine.
Delayed periods since vaccination.  Month of November period was two days late. Month of December was three days late. Month of January it is five days late and I have not had it yet. Three pregnancy tests have been negative the past three days. Have been trying to conceive since October but with the delayed periods and negative ovulations tests since November, It has not happened obviously.
Vaccination site erythema; Vaccination site inflammation; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2019, the patient received Shingrix. On 20th July 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site inflammation. On an unknown date, the outcome of the injection site erythema and injection site inflammation were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site inflammation to be related to Shingrix.  Additional case details were reported as follows: The vaccine lot number and expiry date was not readily available The patient received vaccine in left deltoid. The patient experienced redness and inflammation at the injection site and also complains of it at the time of reporting being unresolved. The reporter stated she had observed this reaction with multiple undisclosed persons. The reporter gave permission to follow up. This case had been linked to the case US2019133826, reported by same reporter. In the XML document outcome of events was reported as recovering, but in database its mentioned as not recovered, so kept as reported in database.
Golf ball size swelling hard to touch pain radiating to axilla and down arm deep bone pain with tenderness to ribs in area: Treatment rested arm/Motrin
Client took 1st typhoid tablet 6-8-13 in the evening 6-9-13 client c/o severe body ache, temp of 103.4 degrees F, back and leg pain. Client took 2nd typhoid tablet 6-9-13 in the evening and vomited within 10 minutes.
This spontaneous report was received from a physician via a company representative referring to a 8 year old patient with preexisting disease. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis. On an unknown date, the patient experienced drug administered to patient of inappropriate age and no adverse event.
1.  I HAVE HEARING DECREASE ON BOTH Ears 2. I HAVE HEADACHE EVER OTHER DAYS 3, I HAVE RINGING NOISE ON BOTH EARS.
Patient report a temperature of 102.8 degrees at noon on 10/05/2017. She also noted some lower back pain that radiated to her neck. She report lip and tongue tingling, but no difficulty in breathing. She went to the Clinic at 4:20 pm. She was given 50mg diphenhydramine IV, along with 125mg Methylprednisolone and 1mg ondansetron. She felt better immediately and said she was breathing more easily. She was sent home on a tapering dose of prednisone: 20mg three times a day for 1 day, 20mg twice a day for 1 day and 20mg once a day for 1 day. She was told to take diphenhydramine 50mg orally each day. There were no labs drawn. The suspected a reaction to the flu shot (AFLURIA), since she did not receive any other medication that day.
Arm hurt; Felt like she was about to die; A lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), FEELING ABNORMAL (Felt like she was about to die) and PAIN (A lot of pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt), FEELING ABNORMAL (Felt like she was about to die) and PAIN (A lot of pain). At the time of the report, PAIN IN EXTREMITY (Arm hurt), FEELING ABNORMAL (Felt like she was about to die) and PAIN (A lot of pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a physician via company representative refers to a 87 year old female patient. On an unknown date in 2010, the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). Concomitant therapies included gabapentin (manufacturer unknown). On 05-MAY-2014, the patient experienced shingles. The patient sought medical attention on 05-MAY-2014 and visited the physician's office. On 05-MAY-2014, the patient was diagnosed with shingles on her left interior shoulder. The patient was treated with acyclovir (unspecified dose, frequency and manufacturer). The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
This is an elderly 72-year-old female who is an ongoing smoker with  a known history of COPD on home O2 at the nursing home, possibly 2 L p.r.n.  was out smoking and then had an unwitnessed syncopal episode.  Was sent to the  emergency room on 9/17/21 where she was found to be hypotensive and in respiratory  distress.  Her hemoglobin was found to be only 4.3.  Patient was started on a  BiPAP and then the hospitalist service was called for admission.  Patient  denies any history of epistaxis, hemoptysis, hematemesis, melena,  hematochezia, hematuria, and she is not on any blood thinning medications.   Her rectal exam revealed OB negative stool.  The patient is denying abdominal  pain.  She does complain of feeling lightheaded.  She does have a history of  chronic anemia, but her baseline hemoglobin runs around 9.3, which was there  in February of this year.  At that point of time, her MCV was 88.6.   Currently, her H and H is 4.7 and 18.5 with an MCV of 61.5.  I have ordered  stat anemia workup on her and a CT abdomen and pelvis and chest as well.  Her  COVID test did come back as positive.   She will be going up to the IMC as an  inpatient.  Started her on Rocephin because her urinalysis is abnormal and  the chest x-ray, there is a possibility of some COVID related pneumonia as  well. Patient rececived and completed all 5 doses of remdesivir and 10 days of dexamethasone. Placed on ampicillin on 10/2/21. Discharged on 10/14/2021
After 5 minutes of receiving shots (MCV4 and HPV), patient started to feel dizzy, pt was taken to an exam room and there patient fainted. Kept ger in the room for another five minutes, pt stated she was feeling better and was ready to leave, informed patient to wait in the waiting room for an additional ten minutes. After 10 minutes pt stated feeling nauseous, took her back to an exam room, pt started vomiting, and feeling dizzy again, had pt lay down for another few minutes, check B/P, and vitals patient was stable. Patient waited for another 20 minutes, started feeling better and was sent home.
residual headache; felt about 50% of his usual self; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "suspected COVID-19", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (1st dose), for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious) with onset 01Apr2021, outcome "recovering", described as "felt about 50% of his usual self"; HEADACHE (non-serious) with onset 02Apr2021, outcome "recovering", described as "residual headache".   Additional information: The patient was 50 (unit not reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chest pain, shortness of breath, nausea, lightheadedness; brief loss of consciousness. Diagnosed with pericarditis.
PATIENT WAS ONLY 16 AT TIME OF VACCINATION, AND HAD NO LEGAL GUARDIAN OR PARENT PRESENT TO SIGN THE VACCINE ADMINISTRATION RECORD. PATIENT SIGNED IT HIMSELF.
Patient reported on Tuesday (05/22/19) evening @ approx. 7:30 pm Sweating and chills beginning approximately 3 hours after vaccination (on 05/17/19) Nausea and vomiting since Saturday (05/18/19) Abdominal pain since Sunday (05/19/19) Per patient she has not eaten since vaccination
Diarrhea and severe stomach cramping. Couldn?t keep anything in and still have a bit of a queasy stomach 5 days later.
pt recvd vax & had severe joint swelling; of ankles; knees; hands; elbows; saw MD-referral to neurologist; EMG & NCS nl;
My father received a tetanus shot on 8/31 because he stepped on a wire. On 9/6, he woke up not feeling well. 9/7- severe pain in ear, neck and throat. Went back to Dr and flu test negative and ear clear. 9/8- awoke with neuropathy flare up in feet along with severe lower back pain. Couldn't swallow Admitted to hospital. All test negative other than some arthritis and bone spurs. 9/9 discharged home. Slept all day. 9/10 back to dr having difficulty swallowing, stiff neck, shoulders killing him. 9/11 back to dr with stiff neck, jaw pain, unable to swallow, aching all over. 9/12- back to Dr with above symptoms and now having bad hip pain and pain in back of head. Admitted back to hospital. Still in hospital awaiting consults from neurologist, infectious disease, more testing. All test are coming back negative so far which leads me to believe this is a reaction to the vaccine.
Immediately after the injection, I felt a flush from head to toe, dizziness, weakness in legs & tingling.  Subsequent from theses symptoms, I felt anxiety and experienced an anxiety attack that I have experienced in the past.
Severe diarrhea / Resolved with rest, increased fluid intake and temporary change in diet / Lasted one day
Diahrrea, dark green stool, made bottom raw. Nothing has helped with this since.
6 hours after vaccine administration, patient was itchy. 9 hours after vaccine administration, skin reddened bilaterally on arms. Over next three days, progressive  red rash and itching occurred over arms, chest, back.  On 3/8 rash progressed over both legs, neck, face, and mouth. Patient also experienced swelling in gums and severe facial redness. Patient also had facial swelling and scalp tightness and itchiness. Patient sought medical care at Center on 3/10. She was treated with  titrated over 6 days, and Zyrtec 10 mg daily.
On Saturday 3/31/18 patient received 4 vaccines in our pharmacy. In her left arm she received ENGERIX B (NDC 58160-0821-43) and SHINGRIX (NDC 58160-0828-03) - ENGERIX B was upper and SHINGRIX was lower. In her right arm she received HAVRIX (NDC 58160-0826-43) and BOOSTRIX (NDC 58160-0842-43) - HAVRIX was lower and BOOSTRIX was upper. Today 4/3/18 (Tuesday) patient came in with swelling and redness in her left arm. She said that Saturday the swelling was much more severe and red. She states that it is warm to touch and itches really bad. She wanted to know what she should do. I recommended OTC therapy to help with symptoms but recommend she see her PCP in the event that it is infected. She said she would try the OTC therapy and if symptoms did not continue to get better she would see her doctor. She said she was a wellness check next Monday she would talk to her doctor then. I told her we would also be contacting her doctor to let her know.
I received a flu shot at my local pharmacy a week and a half ago.  I received it in my left arm. Injection was give too high and I had pain immediately and an inflammatory response. It is two weeks and the pain contniues in the shoulder and arm area with limiting range of motion and pain.
within 30 sec - tachycardia and HTN - tachycardia persisted  4 mo
Stated that it looks like a lump on her armpit when she lifts her arm.; it was painful and anything that it touches that it hurts; something that appeared as a boil; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 (Lot number: EP533) at the age of 30 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), for COVID-19 immunisation. The following information was reported: AXILLARY MASS (non-serious) with onset 10Apr2021, outcome "not recovered", described as "Stated that it looks like a lump on her armpit when she lifts her arm."; PAIN (non-serious) with onset 10Apr2021, outcome "not recovered", described as "it was painful and anything that it touches that it hurts"; FURUNCLE (non-serious) with onset 10Apr2021, outcome "unknown", described as "something that appeared as a boil". The events "stated that it looks like a lump on her armpit when she lifts her arm." and "it was painful and anything that it touches that it hurts" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of axillary mass, pain.  Additional information: she had the Pfizer vaccine second dose on 09 Apr and stated that she was going to go to the doctor because it was painful and anything that it touches that it hurts. Stated that it looks like a lump on her armpit when she lifts her arm and it has not gone away. Clarified the something that appeared as a boil. Wanted to know when it is going away and what should she do.   No follow-up attempts are possible. No further information is expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: before vaccination, pt indicated that she doesn't do well in needles. she experiences panic attacks with needles. pt complained of lightheadedness, nausea,flushed, warm feeling. gave pt a trashcan but didnt vomit. gave a cool compress, and pt already had h20 to drink. after sitting over 30 minutes, pt boyfriend came to p/u pt. called pt. pt is doing much better also indicated she had some blurred vision also.
Swollen, red,  hot,  painful arm, armpit, and trap muscle ipsilateral of injection site. Accompanied by headache, epigastric and RUQ abdominal pain and nausea. This happened the day after the injection and has continued to today (3rd day following 2nd Moderna vaccine shot). I had no reactions after the 1st shot.
Presented to clinic for Covid shot, filled out paperwork, noted penicillin for allergies. She noted she felt sick and funny after her first dose, proceeded to ask if she would like it, and still gave consent to have it done.