chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rectal bleeding; Pain; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. This consumer reported same events under same suspect product for 3 patients. This is 3 of 3 reports.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RECTAL HAEMORRHAGE (medically significant), outcome "unknown", described as "Rectal bleeding"; PAIN (non-serious), outcome "unknown", described as "Pain"; NAUSEA (non-serious), outcome "unknown", described as "Nausea". Clinical course: Reporter mentioned she (reporter) had several friends who had 3 doses of Pfizer COVID-19 vaccine and had severe reactions and also had COVID after being vaccinated. Reporter knew a few people who had reports of palpitations after Pfizer COVID-19 vaccine, and that a couple people complained about having the effects of tinnitus. Reporter told 3 people who had complaints similar to her of rectal bleeding, pain, and nausea. Reporter told she knew one person whose eyesight was blurry and they had been to several doctors who cannot figure out why this persons eyesight was blurry. Reporter confirmed above details during the call, but did not provide any further details about the other people she spoke to. Caller reports that she knows of other people who have had side effects with the Pfizer Covid-19 vaccine (no age or gender information provided)-several friends who have had 3 doses of the Pfizer Covid-19 vaccine and have had severe reactions and were diagnosed with Covid-19 afterwards, a few people who have complaints of palpitations, a couple people who have complaints of tinnitus, 3 people who have complaints similar to her of rectal bleeding, pain, and nausea, and one person with complaints of blurry vision and that persons HCP cannot figure it out.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200343091 same reporter/drug/events, different patients;US-PFIZER INC-202200343093 same reporter/drug/events, different patients
Injection site pain for 2 days, dry cough for about 3 days following injection.
Shaky, felt closed in, patient believes it was anxiety, waited 15 minutes, cleared by EMS.
a fever of 101 degrees Farenheight; upset stomach; headache; mild body aches; Chills; shaking; severe dizziness; felt cold; could not get warm; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (mild body aches), CHILLS (Chills), PYREXIA (a fever of 101 degrees Farenheight) and TREMOR (shaking) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (headache), MYALGIA (mild body aches), CHILLS (Chills), TREMOR (shaking), DIZZINESS (severe dizziness), NASOPHARYNGITIS (felt cold), BODY TEMPERATURE DECREASED (could not get warm) and PYREXIA (slight fever). On an unknown date, the patient experienced PYREXIA (a fever of 101 degrees Farenheight) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, HEADACHE (headache), MYALGIA (mild body aches), CHILLS (Chills), PYREXIA (a fever of 101 degrees Farenheight), TREMOR (shaking), DIZZINESS (severe dizziness), NASOPHARYNGITIS (felt cold), BODY TEMPERATURE DECREASED (could not get warm), PYREXIA (slight fever) and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.
1/28/2021- Sever upper abdominal (stomach aches) pain,  diarrhea, low grade fever (~100 F), and fatigue- No intake of food- fear of adverse abdominal pain.  1/29/2021- Mild abdominal pain , diminish sense of smell and taste, and tired. Took a Covid-19 PCR test. 1/30/2021- Little abdominal pain and diminish sense of smell and taste. 1/31/2021-Diminish sense of smell and taste. 2/1/2021- Diminish sense of smell and taste.  Negative PCR Covid-19 Test.  2/2/2020- Sense of smell and taste restored.
Fever; Headache; Chills; Body ache; This is a spontaneous report from a contactable consumer (Patient's wife). This male patient of unspecified age received the second dose of BNT162B2 on 20Jan2021 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The consumer reported that he got his second shot yesterday, the Covid 19. He started fever, the chills and body ache and he could not get warm and then we checked his temperature this morning it's a 100.1 and he has got headache this morning. The clinical outcome of the events fever, chills, body ache, and headache unknown.  No follow-up attempts are possible. No further information is expected.
Muscle spasms in right hip that traveled down to right foot. Muscle tightness and contractions in abdomen. Very painful. Since I'm pregnant it was alarming.
Patient reported that she started feeling complications the same day. She went to the store and felt dizzy and fell out in the parking lot. The following Wednesday everything she ate she threw it up. She blacked out again. Neighbor called 911. She passed out and awaken in the hospital. She had a server condition of diarrheia. She was hospitalized from the 14th of April to the 27th.  They found out that she had blood clots in her arm after the scan. Hard to raise arm up and could hardly walk. Was put on blood thinner to dissolve the blood clot and was dropping blood pressure. Passed out in the shower. Almost hit head. If she is doing any kind of walking her blood pressure drops. Patient stats that she did not have any of these medical problems since she has taken the vaccine. Patient also states that she has lost weight.
This spontaneous report was received from a nurse prescriber via a company representative and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were unknown. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 injection, intramuscularly (exact dose, lot # and expiry date were not reported) to prevent human papilloma virus (HPV). It was unspecified which dose the patient was receiving. Subsequently, on an unknown date after receiving GARDASIL 9, the patient fainted. The outcome of the event and causality between the event and GARDASIL 9 were not reported. Product quality complaint was not involved. Additional information has been requested.
expired dose of PENTACEL was administered with no reported adverse event; Initial information was received on 13-Dec-2022 regarding an unsolicited valid non-serious case received via call center from a health professional.  This case involves 7 months old female patient who experienced expired dose of pentacel was administered with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine (HEPATITIS B) for Immunisation.  On 13-Dec-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine at a dose of 0.5 ml (lot: UJ598AAA ,U7091AA, Expiry date: 05-Dec-2022) via intramuscular route in the left thigh for prophylactic vaccination.  On 13-Dec-2022 the patient developed a non-serious event of expired dose of pentacel was administered with no reported adverse event (expired product administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, ipv and HIB VACCINE (Pentacel) was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
injection site warm to the touch; rash at the injection site that is about 4 inches; injection site a little sore; little swollen on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warm to the touch), VACCINATION SITE RASH (rash at the injection site that is about 4 inches), VACCINATION SITE PAIN (injection site a little sore) and VACCINATION SITE SWELLING (little swollen on her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site warm to the touch), VACCINATION SITE RASH (rash at the injection site that is about 4 inches), VACCINATION SITE PAIN (injection site a little sore) and VACCINATION SITE SWELLING (little swollen on her arm). At the time of the report, VACCINATION SITE WARMTH (injection site warm to the touch), VACCINATION SITE RASH (rash at the injection site that is about 4 inches), VACCINATION SITE PAIN (injection site a little sore) and VACCINATION SITE SWELLING (little swollen on her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information 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, a causal relationship cannot be excluded.
ITCHY SCALP, BOILS OR SORES AND BOILS THROUGHOUT SCALP, FLAKING.
Visited physician's office 5/17/04 secondary to mild upper respiratory infection; afebrile; Child is asthmatic. Received DTaP and pneumococcal. Returned to office this AM (5/18/04) with extreme lethargy, hypoglycemia, hyperpyrexia (103-105). Transferred via ambulance to hospital.
After the shot, I had the "typical" reaction - sore arm, a bit of a head ache, but nothing concerning.  Then on the 4th night after my shot, I started feeling bad and got in bed.  That night I couldn't sleep due to not feeling well. The next morning I was very dizzy, agitated, nauseous and had a weird head ache behind my eyes.    I started feeling like I was going to throw up anytime I looked at anything for more than about a minute. (my phone, a book, a puzzle, the tv).   I laid by the toilet most of the day with a wash cloth over my eyes. Around 6pm that night I started throwing up a TON, major headache, body aches, shivers, but no fever.   These symptoms lasted for the next two days.  (as a side note, this was during the freeze, so I was not able to call my doctor, etc...).  I started feeling better on day 4 but I had a headache for about two week - that still lingers on most days.  (headaches are unusual for me).  This was, without a doubt, the sickest I have ever been in my life! I decided not to get the 2nd shot because I was afraid of feeling worse after the 2nd shot.
Over last 2 weeks, worsening rash/ psoriasis looking symptoms in both palms, white head bumps with no pus, redness, itchiness,
Flu vaccine was administered right deltoid 12/09/2002. Soreness at injection site intensified and progressed to right shoulder by 12/11/2002 and into left shoulder and arm by 12/13/2002. No improvement noted by 12/16/2002. 12/19/2002 Improved per pt.
Initial report received from pharmacist on 15 Jan 2010: The patient was vaccinated with FLUVIRIN (batch no. 104045P1) on an unknown date. One dose of influenza vaccine that had been stored at temperatures as low as 34F and 35F was given to an adult. No adverse effect was reported.
This case was reported by a health professional in the United States on 21 June 2007. A female patient in her 20's received an injection of Adacel in the emergency room (lot number, route, site, and administration date not provided) following a puncture wound. She subsequently developed chills, fever, headache, muscle and body aches, tiredness, cough, and congestion which persisted for one week following vaccination. The events resolved.
?COVID arm? - a week  after the injection I developed a hard, red, swollen area approximately 2 inches wide around the injection site.  The area slightly itches.
Had to lay down immediately after the shot because of dizziness. 1 weeks later had dizziness, near syncope, parethesias, coldness in her hands and feet, tachycardia all are ongoing to certain extent except dizziness and tachycardia which are occasional mostly on exertion.
Right eye pain, blurry vision, eye injected (red), mild headache, increased eye pain in bright light Treatment: steroid eye drops Prednisolone Acetate One drop to right eye 4 times a day
swelling with blistering on the buccal mucosa about an hour after vaccine was given.  Vaccine administrator reports no problems while giving the vaccine; vaccine was given on the side of the mouth.  Patient and mother left the office but called shortly after to report the symptoms.
Immediately after injection tasted "metallic taste tip of tongue", felt weak and throat tense. Breathing OK and dizzy weakness went away so I walked about store with 5 min. I was a runner but after injection experienced weakness, lack strength and muscle aches and increased joint discomfort. It continues as of March 2015 and is getting worse. Symptoms have diminished some now, but continue to recover.
Covid Arm: red swelling, itching, pain in injection site 8 days after shot.
Eyes itchy, blurry, completely red around 4 PM patient got into shower, throat started to tighten and had difficulty breathing, hives on front of legs, wheezing, coughing, patient went to ER and was given epinephrine, SOLU-MEDROL 60 mg, BENADRYL 50 mg.
Received multiple vaccines on 11-23-09 (see below). Next day - developed full-body rash. Within next 24 hours experienced mild swelling of hands/stiill covered with rash.
Redness to RT thigh and LT thigh administrations site of MMR and Varicella. Watched pt for 1 hr and redness decreased and sent home and examined by Dr.
SNEEZE ATTACK; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number n/a), via nasal route, on an unknown date.     On an unknown date, the patient experienced sneeze attack (preferred term: Sneezing).     It is unknown if any action was taken with Flumist Quadrivalent (influenza virus vaccine live, intranasal).     The outcome of the event was unknown.    The event was considered non-serious.
sleepiness; dizziness; exhaustion; joint pain; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for self that the 68-year-old female patient who received first dose of bnt162b2 (BNT162B2, product: COVID 19, brand: Pfizer, Pfizer-BioNTech, lot: EK5730), via Intramuscular on left Arm on 18Dec2020 08:00 AM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included known allergies to medications, food, or other products: Kenalog, Omnicef. Concomitant medications were unknown. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced dizziness, exhaustion, joint pain, sleepiness from 18Dec2020 08:00 AM and outcome of recovered in Dec2020. No treatment received. No covid prior vaccination. No covid tested post vaccination. The case was assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Cough  Fatigue  Headache  New loss of taste or smell  Sore throat
I now know 11 people who are dead due to these unnecessary evil non vaccines; This is a spontaneous report from a contactable consumer. This consumer reported for eleven patients. This case is part of a batch of eleven cases reporting dead for BNT162B2. This is the second of eleven people.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated that now he knew eleven people who were dead due to these unnecessary evil non-vaccines. The patient died due to unknown cause of death on an unspecified date.  It was not reported if an autopsy was performed.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Reported Cause(s) of Death: I now know 11 people who are dead due to these unnecessary evil non vaccines
Pregnant; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnant) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PREGNANCY (Pregnant) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure during pregnancy). At the time of the report, PREGNANCY (Pregnant) outcome was unknown and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided    No concomitant medications were reported. Treatment information was not provided. Company Comment: This case concerns a female patient of unknown age with no details on relevant medical history, who experienced Vaccine exposure before pregnancy associated with mRNA- 1273 Moderna vaccine. The patient received the second dose of the vaccine approximately 7 to 8 months before gestation. No adverse events were reported. The benefit-risk relationship of mRNA- 1273 vaccine Moderna Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a female patient of unknown age with no details on relevant medical history, who experienced Vaccine exposure before pregnancy associated with mRNA- 1273 Moderna vaccine. The patient received the second dose of the vaccine approximately 7 to 8 months before gestation. No adverse events were reported. The benefit-risk relationship of mRNA- 1273 vaccine Moderna Vaccine is not affected by this report.
LOST CONSCIOUSNESS; COLD TO THE TOUCH; SWEATY; This spontaneous report received from a consumer concerned a 25 year old male. The patient's weight was 68 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with azithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 07-JUL-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, few minutes after the vaccination, the patient lost consciousness and regained it a minute later. The patient was also cold to the touch and sweaty. The patient had visited the doctor/healthcare professional office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost consciousness, cold to the touch, and sweaty on 07-JUL-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210718535- covid-19 vaccine ad26.cov2.s-Lost consciousness. This event(s) is considered un-assessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB lot # M032649 and lot # reported as M002914 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. Lot number M002914 is an invalid lot number for RECOMBIVAX HB. Sender's Comments: US-009507513-1708USA012995: US-009507513-1708USA012994.
Information was received from a 64 year old female patient with diabetes, high blood pressure, high cholesterol, asthma, and no known allergies. The patient stated "she is on several medications" (unspecified). On 06-MAR-2017, the patient was vaccinated with ZOSTAVAX injection, "one time vaccine," (lot number, dosage, and route of administration not provided) to prevent shingles. On approximately 20-MAR-2017 (reported as two weeks after getting the vaccine), the patient had very bad pain in her right arm. She then developed a rash on her right arm (specific onset unknown).  The pain in her right arm subsided somewhat and was not as painful. Then on approximately 17-MAY-2017 (reported as two days ago), the patient developed a sharp pain on the right side of her head. The patient sought medical attention on an unknown date and was prescribed valacyclovir for the pain in her head. She reported having a blood test done on approximately 28-APR-2017 (reported as 3 weeks ago; results not provided). The outcome of the rash and sharp pain on the right side of her head is unknown. No further information was provided. Additional information has been requested.
Woke up at 12:40 in the morning and was covered in hives and my face and ears were swollen
Left breast and nipple pain started approximately 6 weeks after the second injection.   I saw the Midwife and she said it could possibly be related to my vaccine as she has been seeing patients coming in with similar pain after Covid injections.  I was put on Diflucan as it possibly could have been yeast, but the medication did not resolve the left breast pain and I still get pain in the left nipple and breast on occasion.